{ "twins_schema": "1.0", "disclaimer": "Not legal advice: this output is machine-computed from published texts, carries no lawyer's review, and is engineering assistance only.", "method": { "measure": "word-ratio", "floor": 0.9, "verified_on": "2026-10-19" }, "a": { "corpus": "eu", "key": "32017R0745", "version": "02017R0745-20260719" }, "b": { "corpus": "eu", "key": "32017R0746", "version": "02017R0746-20250110" }, "pairs": [ { "a": "AR 4", "b": "AR 3", "ratio": 0.921, "identical": false, "numbering_only": false, "children": [ { "a": "AR 4 PA 2", "b": "AR 3 PA 2", "ratio": 0.979 }, { "a": "AR 4 PA 2 ALN 1", "b": "AR 3 PA 2 ALN 1", "ratio": 0.978 }, { "a": "AR 4 PA 3", "b": "AR 3 PA 3", "ratio": 0.962 }, { "a": "AR 4 PA 3 ALN 1", "b": "AR 3 PA 3 ALN 1", "ratio": 0.961 }, { "a": "AR 4 PA 4", "b": "AR 3 PA 4", "ratio": 0.962 }, { "a": "AR 4 PA 4 ALN 1", "b": "AR 3 PA 4 ALN 1", "ratio": 0.961 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 5", "b": "AR 5", "ratio": 0.907, "identical": false, "numbering_only": false, "children": [ { "a": "AR 5 PA 1", "b": "AR 5 PA 1", "ratio": 1.0 }, { "a": "AR 5 PA 1 ALN 1", "b": "AR 5 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 5 PA 2", "b": "AR 5 PA 2", "ratio": 1.0 }, { "a": "AR 5 PA 2 ALN 1", "b": "AR 5 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 5 PA 3", "b": "AR 5 PA 3", "ratio": 0.905 }, { "a": "AR 5 PA 3 ALN 1", "b": "AR 5 PA 3 ALN 1", "ratio": 0.9 }, { "a": "AR 5 PA 6", "b": "AR 5 PA 6", "ratio": 0.979 }, { "a": "AR 5 PA 6 ALN 1", "b": "AR 5 PA 6 ALN 1", "ratio": 0.979 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 6", "b": "AR 6", "ratio": 0.991, "identical": false, "numbering_only": false, "children": [ { "a": "AR 6 PA 1", "b": "AR 6 PA 1", "ratio": 1.0 }, { "a": "AR 6 PA 1 ALN 1", "b": "AR 6 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 6 PA 2", "b": "AR 6 PA 2", "ratio": 0.978 }, { "a": "AR 6 PA 2 ALN 1", "b": "AR 6 PA 2 ALN 1", "ratio": 0.978 }, { "a": "AR 6 PA 3", "b": "AR 6 PA 3", "ratio": 1.0 }, { "a": "AR 6 PA 3 ALN 1", "b": "AR 6 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 6 PA 4", "b": "AR 6 PA 4", "ratio": 1.0 }, { "a": "AR 6 PA 4 ALN 1", "b": "AR 6 PA 4 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "offered by means of information society services as defined in point (b) of", "b": "offered by means of information society services, as defined in point (b) of", "cut": false }, { "a": "of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication,", "b": "of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication,", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 7", "b": "AR 7", "ratio": 0.989, "identical": false, "numbering_only": false, "children": [ { "a": "AR 7 ALN 1", "b": "AR 7 ALN 1", "ratio": 0.989 }, { "a": "AR 7 ALN 1 PTA (a)", "b": "AR 7 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 7 ALN 1 PTA (b)", "b": "AR 7 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 7 ALN 1 PTA (c)", "b": "AR 7 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 7 ALN 1 PTA (d)", "b": "AR 7 ALN 1 PTA (d)", "ratio": 1.0 } ], "passages": [ { "a": "be prohibited to use text, names, trade marks, pictures and figurative or other signs", "b": "be prohibited to use text, names, trademarks, pictures and figurative or other signs", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 8", "b": "AR 8", "ratio": 0.923, "identical": false, "numbering_only": false, "children": [ { "a": "AR 8 PA 1", "b": "AR 8 PA 1", "ratio": 0.962 }, { "a": "AR 8 PA 1 ALN 1", "b": "AR 8 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 8 PA 1 ALN 3", "b": "AR 8 PA 1 ALN 3", "ratio": 1.0 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 10", "b": "AR 10", "ratio": 0.931, "identical": false, "numbering_only": false, "children": [ { "a": "AR 10 PA 1", "b": "AR 10 PA 1", "ratio": 1.0 }, { "a": "AR 10 PA 1 ALN 1", "b": "AR 10 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 10 PA 2", "b": "AR 10 PA 2", "ratio": 1.0 }, { "a": "AR 10 PA 2 ALN 1", "b": "AR 10 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 10 PA 4", "b": "AR 10 PA 4", "ratio": 0.944 }, { "a": "AR 10 PA 4 ALN 1", "b": "AR 10 PA 4 ALN 1", "ratio": 0.936 }, { "a": "AR 10 PA 4 ALN 2", "b": "AR 10 PA 4 ALN 2", "ratio": 0.96 }, { "a": "AR 10 PA 9", "b": "AR 10 PA 8", "ratio": 0.96 }, { "a": "AR 10 PA 9 ALN 1", "b": "AR 10 PA 8 ALN 1", "ratio": 0.953 }, { "a": "AR 10 PA 9 ALN 2", "b": "AR 10 PA 8 ALN 2", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3", "b": "AR 10 PA 8 ALN 3", "ratio": 0.959 }, { "a": "AR 10 PA 9 ALN 3 PTA (a)", "b": "AR 10 PA 8 ALN 3 PTA (a)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (b)", "b": "AR 10 PA 8 ALN 3 PTA (b)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (c)", "b": "AR 10 PA 8 ALN 3 PTA (c)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (d)", "b": "AR 10 PA 8 ALN 3 PTA (d)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (e)", "b": "AR 10 PA 8 ALN 3 PTA (e)", "ratio": 0.96 }, { "a": "AR 10 PA 9 ALN 3 PTA (g)", "b": "AR 10 PA 8 ALN 3 PTA (g)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (h)", "b": "AR 10 PA 8 ALN 3 PTA (h)", "ratio": 0.931 }, { "a": "AR 10 PA 9 ALN 3 PTA (i)", "b": "AR 10 PA 8 ALN 3 PTA (i)", "ratio": 0.933 }, { "a": "AR 10 PA 9 ALN 3 PTA (j)", "b": "AR 10 PA 8 ALN 3 PTA (j)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (k)", "b": "AR 10 PA 8 ALN 3 PTA (k)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (l)", "b": "AR 10 PA 8 ALN 3 PTA (l)", "ratio": 1.0 }, { "a": "AR 10 PA 9 ALN 3 PTA (m)", "b": "AR 10 PA 8 ALN 3 PTA (m)", "ratio": 1.0 }, { "a": "AR 10 PA 10", "b": "AR 10 PA 9", "ratio": 0.9 }, { "a": "AR 10 PA 10 ALN 1", "b": "AR 10 PA 9 ALN 1", "ratio": 0.947 }, { "a": "AR 10 PA 12", "b": "AR 10 PA 11", "ratio": 0.976 }, { "a": "AR 10 PA 12 ALN 1", "b": "AR 10 PA 11 ALN 1", "ratio": 0.986 }, { "a": "AR 10 PA 12 ALN 2", "b": "AR 10 PA 11 ALN 2", "ratio": 0.981 }, { "a": "AR 10 PA 14", "b": "AR 10 PA 13", "ratio": 0.997 }, { "a": "AR 10 PA 14 ALN 1", "b": "AR 10 PA 13 ALN 1", "ratio": 1.0 }, { "a": "AR 10 PA 14 ALN 2", "b": "AR 10 PA 13 ALN 2", "ratio": 1.0 }, { "a": "AR 10 PA 14 ALN 3", "b": "AR 10 PA 13 ALN 3", "ratio": 1.0 }, { "a": "AR 10 PA 14 ALN 4", "b": "AR 10 PA 13 ALN 4", "ratio": 1.0 }, { "a": "AR 10 PA 15", "b": "AR 10 PA 14", "ratio": 0.946 }, { "a": "AR 10 PA 15 ALN 1", "b": "AR 10 PA 14 ALN 1", "ratio": 0.972 }, { "a": "AR 10 PA 16", "b": "AR 10 PA 15", "ratio": 0.986 }, { "a": "AR 10 PA 16 ALN 1", "b": "AR 10 PA 15 ALN 1", "ratio": 1.0 }, { "a": "AR 10 PA 16 ALN 2", "b": "AR 10 PA 15 ALN 2", "ratio": 1.0 } ], "passages": [ { "a": "I. 3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements", "b": "I. 3. Manufacturers shall conduct a performance evaluation in accordance with the requirements", "cut": false }, { "a": "the requirements set out in Article 61 and Annex XIV, including a PMCF.", "b": "the requirements set out in Article 56 and Annex XIII, including a PMPF.", "cut": false }, { "a": "out in Article 61 and Annex XIV, including a PMCF. 4. Manufacturers of", "b": "out in Article 56 and Annex XIII, including a PMPF. 4. Manufacturers shall", "cut": false }, { "a": "61 and Annex XIV, including a PMCF. 4. Manufacturers of devices other than", "b": "56 and Annex XIII, including a PMPF. 4. Manufacturers shall draw up and", "cut": false }, { "a": "XIV, including a PMCF. 4. Manufacturers of devices other than custom-made devices shall draw up and keep up", "b": "XIII, including a PMPF. 4. Manufacturers shall draw up and keep up", "cut": false }, { "a": "up and keep up to date technical documentation for those devices. The", "b": "up and keep up to date the technical documentation for those devices. The", "cut": false }, { "a": "delegated acts in accordance with Article 115 amending, in the light of technical", "b": "delegated acts in accordance with Article 108 amending, in the light of technical", "cut": false }, { "a": "the Annexes II and III. 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII. 6. Where compliance with the applicable requirements", "b": "the Annexes II and III. 5. Where compliance with the applicable requirements", "cut": false }, { "a": "procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration", "b": "procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration", "cut": false }, { "a": "of conformity in accordance with Article 19, and affix the CE marking of", "b": "of conformity in accordance with Article 17, and affix the CE marking of", "cut": false }, { "a": "of conformity in accordance with Article 20. 7. Manufacturers shall comply with the obligations", "b": "of conformity in accordance with Article 18. 6. Manufacturers shall comply with the obligations", "cut": false }, { "a": "UDI system referred to in Article 27 and with the registration obligations referred", "b": "UDI system referred to in Article 24 and with the registration obligations referred", "cut": false } ], "passages_omitted": 28, "passages_withheld": false, "headings_equal": true }, { "a": "AR 10a", "b": "AR 10a", "ratio": 0.981, "identical": false, "numbering_only": false, "children": [ { "a": "AR 10a PA 1", "b": "AR 10a PA 1", "ratio": 0.975 }, { "a": "AR 10a PA 1 ALN 1", "b": "AR 10a PA 1 ALN 1", "ratio": 0.963 }, { "a": "AR 10a PA 1 ALN 2", "b": "AR 10a PA 1 ALN 2", "ratio": 1.0 }, { "a": "AR 10a PA 2", "b": "AR 10a PA 2", "ratio": 1.0 }, { "a": "AR 10a PA 2 ALN 1", "b": "AR 10a PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 10a PA 3", "b": "AR 10a PA 3", "ratio": 0.981 }, { "a": "AR 10a PA 3 ALN 1", "b": "AR 10a PA 3 ALN 1", "ratio": 0.981 } ], "passages": [ { "a": "discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable", "b": "discontinuation of the supply of a device and where it is reasonably foreseeable", "cut": false }, { "a": "to whom they directly supply the device, of the anticipated interruption or discontinuation.", "b": "to whom they directly supply the device of the anticipated interruption or discontinuation.", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 11", "b": "AR 11", "ratio": 0.982, "identical": false, "numbering_only": false, "children": [ { "a": "AR 11 PA 1", "b": "AR 11 PA 1", "ratio": 1.0 }, { "a": "AR 11 PA 1 ALN 1", "b": "AR 11 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 11 PA 2", "b": "AR 11 PA 2", "ratio": 1.0 }, { "a": "AR 11 PA 2 ALN 1", "b": "AR 11 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 11 PA 3", "b": "AR 11 PA 3", "ratio": 0.982 }, { "a": "AR 11 PA 3 ALN 1", "b": "AR 11 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2", "b": "AR 11 PA 3 ALN 2", "ratio": 0.979 }, { "a": "AR 11 PA 3 ALN 2 PTA (a)", "b": "AR 11 PA 3 ALN 2 PTA (a)", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2 PTA (b)", "b": "AR 11 PA 3 ALN 2 PTA (b)", "ratio": 0.958 }, { "a": "AR 11 PA 3 ALN 2 PTA (d)", "b": "AR 11 PA 3 ALN 2 PTA (d)", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2 PTA (e)", "b": "AR 11 PA 3 ALN 2 PTA (e)", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2 PTA (f)", "b": "AR 11 PA 3 ALN 2 PTA (f)", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2 PTA (g)", "b": "AR 11 PA 3 ALN 2 PTA (g)", "ratio": 1.0 }, { "a": "AR 11 PA 3 ALN 2 PTA (h)", "b": "AR 11 PA 3 ALN 2 PTA (h)", "ratio": 1.0 }, { "a": "AR 11 PA 5", "b": "AR 11 PA 5", "ratio": 1.0 }, { "a": "AR 11 PA 5 ALN 1", "b": "AR 11 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 11 PA 6", "b": "AR 11 PA 6", "ratio": 0.983 }, { "a": "AR 11 PA 6 ALN 1", "b": "AR 11 PA 6 ALN 1", "ratio": 0.983 }, { "a": "AR 11 PA 7", "b": "AR 11 PA 7", "ratio": 1.0 }, { "a": "AR 11 PA 7 ALN 1", "b": "AR 11 PA 7 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "supplements, issued in accordance with Article 56, at the disposal of competent authorities", "b": "supplements, issued in accordance with Article 51, at the disposal of competent authorities", "cut": false }, { "a": "the period referred to in Article 10(8); (c) comply with the registration obligations", "b": "the period referred to in Article 10(7); (c) comply with the registration obligations", "cut": false }, { "a": "registration obligations laid down in Article 31 and verify that the manufacturer has", "b": "registration obligations laid down in Article 28 and verify that the manufacturer has", "cut": false }, { "a": "the registration obligations laid down in Articles 27 and 29; (d) in response to a request", "b": "the registration obligations laid down in Article 26; (d) in response to a request", "cut": false }, { "a": "in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and", "b": "in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).", "cut": false }, { "a": "Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). 5.", "b": "10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11). 5. Without", "cut": false }, { "a": "(2), (3), (4), (6), (7), (9), (10), (11) and (12). 5. Without prejudice to", "b": "(3), (4), (5), (6), (8), (9), (10) and (11). 5. Without prejudice to", "cut": false }, { "a": "(6), (7), (9), (10), (11) and (12). 5. Without prejudice to paragraph 4", "b": "(5), (6), (8), (9), (10) and (11). 5. Without prejudice to paragraph 4", "cut": false }, { "a": "who terminates its mandate on the ground referred to in point (h) of", "b": "who terminates its mandate on the grounds referred to in point (h) of", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 12", "b": "AR 12", "ratio": 1.0, "identical": true, "numbering_only": false, "children": [ { "a": "AR 12 ALN 1", "b": "AR 12 ALN 1", "ratio": 1.0 }, { "a": "AR 12 ALN 1 PTA (a)", "b": "AR 12 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 12 ALN 1 PTA (b)", "b": "AR 12 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 12 ALN 1 PTA (c)", "b": "AR 12 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 12 ALN 1 PTA (d)", "b": "AR 12 ALN 1 PTA (d)", "ratio": 1.0 } ], "passages": [], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 13", "b": "AR 13", "ratio": 0.988, "identical": false, "numbering_only": false, "children": [ { "a": "AR 13 PA 1", "b": "AR 13 PA 1", "ratio": 1.0 }, { "a": "AR 13 PA 1 ALN 1", "b": "AR 13 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 13 PA 2", "b": "AR 13 PA 2", "ratio": 0.994 }, { "a": "AR 13 PA 2 ALN 1", "b": "AR 13 PA 2 ALN 1", "ratio": 0.989 }, { "a": "AR 13 PA 2 ALN 1 PTA (a)", "b": "AR 13 PA 2 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 13 PA 2 ALN 1 PTA (b)", "b": "AR 13 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 13 PA 2 ALN 1 PTA (c)", "b": "AR 13 PA 2 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 13 PA 2 ALN 1 PTA (d)", "b": "AR 13 PA 2 ALN 1 PTA (d)", "ratio": 0.938 }, { "a": "AR 13 PA 2 ALN 2", "b": "AR 13 PA 2 ALN 2", "ratio": 1.0 }, { "a": "AR 13 PA 3", "b": "AR 13 PA 3", "ratio": 1.0 }, { "a": "AR 13 PA 3 ALN 1", "b": "AR 13 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 13 PA 4", "b": "AR 13 PA 4", "ratio": 0.935 }, { "a": "AR 13 PA 4 ALN 1", "b": "AR 13 PA 4 ALN 1", "ratio": 0.933 }, { "a": "AR 13 PA 5", "b": "AR 13 PA 5", "ratio": 1.0 }, { "a": "AR 13 PA 5 ALN 1", "b": "AR 13 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 13 PA 6", "b": "AR 13 PA 6", "ratio": 1.0 }, { "a": "AR 13 PA 6 ALN 1", "b": "AR 13 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 13 PA 7", "b": "AR 13 PA 7", "ratio": 0.984 }, { "a": "AR 13 PA 7 ALN 1", "b": "AR 13 PA 7 ALN 1", "ratio": 0.984 }, { "a": "AR 13 PA 8", "b": "AR 13 PA 8", "ratio": 1.0 }, { "a": "AR 13 PA 8 ALN 1", "b": "AR 13 PA 8 ALN 1", "ratio": 1.0 }, { "a": "AR 13 PA 9", "b": "AR 13 PA 9", "ratio": 0.925 }, { "a": "AR 13 PA 9 ALN 1", "b": "AR 13 PA 9 ALN 1", "ratio": 0.923 }, { "a": "AR 13 PA 10", "b": "AR 13 PA 10", "ratio": 1.0 }, { "a": "AR 13 PA 10 ALN 1", "b": "AR 13 PA 10 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "the manufacturer in accordance with Article 27. Where an importer considers or has", "b": "the manufacturer in accordance with Article 24. Where an importer considers or has", "cut": false }, { "a": "electronic system in accordance with Article 29. Importers shall add their details to", "b": "electronic system in accordance with Article 26. Importers shall add their details to", "cut": false }, { "a": "the registration in accordance with Article 31. 5. Importers shall ensure that, while", "b": "the registration in accordance with Article 28. 5. Importers shall ensure that, while", "cut": false }, { "a": "into conformity, to withdraw or recall it is taken. Where the device presents", "b": "into conformity, to withdraw or recall it, is taken. Where the device presents", "cut": false }, { "a": "a certificate in accordance with Article 56 for the device in question, giving", "b": "a certificate in accordance with Article 51 for the device in question, giving", "cut": false }, { "a": "the period referred to in Article 10(8), keep a copy of the EU", "b": "the period referred to in Article 10(7), keep a copy of the EU", "cut": false }, { "a": "and, if applicable, a copy of any relevant certificate, including any amendments and", "b": "and, if applicable, a copy of the relevant certificate, including any amendments and", "cut": false }, { "a": "supplements, issued in accordance with Article 56. 10. Importers shall cooperate with competent", "b": "supplements, issued in accordance with Article 51. 10. Importers shall cooperate with competent", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 14", "b": "AR 14", "ratio": 0.994, "identical": false, "numbering_only": false, "children": [ { "a": "AR 14 PA 1", "b": "AR 14 PA 1", "ratio": 1.0 }, { "a": "AR 14 PA 1 ALN 1", "b": "AR 14 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 14 PA 2", "b": "AR 14 PA 2", "ratio": 0.988 }, { "a": "AR 14 PA 2 ALN 1", "b": "AR 14 PA 2 ALN 1", "ratio": 0.983 }, { "a": "AR 14 PA 2 ALN 1 PTA (a)", "b": "AR 14 PA 2 ALN 1 PTA (a)", "ratio": 0.976 }, { "a": "AR 14 PA 2 ALN 1 PTA (b)", "b": "AR 14 PA 2 ALN 1 PTA (b)", "ratio": 0.947 }, { "a": "AR 14 PA 2 ALN 1 PTA (c)", "b": "AR 14 PA 2 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 14 PA 2 ALN 1 PTA (d)", "b": "AR 14 PA 2 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 14 PA 2 ALN 2", "b": "AR 14 PA 2 ALN 2", "ratio": 1.0 }, { "a": "AR 14 PA 2 ALN 3", "b": "AR 14 PA 2 ALN 3", "ratio": 0.989 }, { "a": "AR 14 PA 3", "b": "AR 14 PA 3", "ratio": 1.0 }, { "a": "AR 14 PA 3 ALN 1", "b": "AR 14 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 14 PA 4", "b": "AR 14 PA 4", "ratio": 0.992 }, { "a": "AR 14 PA 4 ALN 1", "b": "AR 14 PA 4 ALN 1", "ratio": 0.992 }, { "a": "AR 14 PA 5", "b": "AR 14 PA 5", "ratio": 1.0 }, { "a": "AR 14 PA 5 ALN 1", "b": "AR 14 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 14 PA 6", "b": "AR 14 PA 6", "ratio": 1.0 }, { "a": "AR 14 PA 6 ALN 1", "b": "AR 14 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 14 PA 6 ALN 2", "b": "AR 14 PA 6 ALN 2", "ratio": 1.0 } ], "passages": [ { "a": "device has been CE marked and that the EU declaration of conformity of", "b": "device has been CE marked and the EU declaration of conformity of", "cut": false }, { "a": "the manufacturer in accordance with Article 10(11); (c) for imported devices, the importer", "b": "the manufacturer in accordance with Article 10(10); (c) for imported devices, the importer", "cut": false }, { "a": "until it has been brought into conformity, and shall inform the manufacturer and,", "b": "until it has been brought into conformity and shall inform the manufacturer and,", "cut": false }, { "a": "co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the", "b": "co-operate with the manufacturer and, where applicable the manufacturer's authorised representative, and the", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 15", "b": "AR 15", "ratio": 0.909, "identical": false, "numbering_only": false, "children": [ { "a": "AR 15 PA 2", "b": "AR 15 PA 2", "ratio": 0.992 }, { "a": "AR 15 PA 2 ALN 1", "b": "AR 15 PA 2 ALN 1", "ratio": 0.992 }, { "a": "AR 15 PA 4", "b": "AR 15 PA 4", "ratio": 1.0 }, { "a": "AR 15 PA 4 ALN 1", "b": "AR 15 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 15 PA 5", "b": "AR 15 PA 5", "ratio": 1.0 }, { "a": "AR 15 PA 5 ALN 1", "b": "AR 15 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 15 PA 6", "b": "AR 15 PA 6", "ratio": 0.965 }, { "a": "AR 15 PA 6 ALN 1", "b": "AR 15 PA 6 ALN 1", "ratio": 0.965 }, { "a": "AR 15 PA 6 ALN 1 PTA (a)", "b": "AR 15 PA 6 ALN 1 PTA (a)", "ratio": 0.976 }, { "a": "AR 15 PA 6 ALN 1 PTA (b)", "b": "AR 15 PA 6 ALN 1 PTA (b)", "ratio": 0.923 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 16", "b": "AR 16", "ratio": 0.994, "identical": false, "numbering_only": false, "children": [ { "a": "AR 16 PA 1", "b": "AR 16 PA 1", "ratio": 0.991 }, { "a": "AR 16 PA 1 ALN 1", "b": "AR 16 PA 1 ALN 1", "ratio": 0.996 }, { "a": "AR 16 PA 1 ALN 1 PTA (a)", "b": "AR 16 PA 1 ALN 1 PTA (a)", "ratio": 0.991 }, { "a": "AR 16 PA 1 ALN 1 PTA (b)", "b": "AR 16 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 16 PA 1 ALN 1 PTA (c)", "b": "AR 16 PA 1 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 16 PA 1 ALN 2", "b": "AR 16 PA 1 ALN 2", "ratio": 0.976 }, { "a": "AR 16 PA 2", "b": "AR 16 PA 2", "ratio": 0.995 }, { "a": "AR 16 PA 2 ALN 1", "b": "AR 16 PA 2 ALN 1", "ratio": 0.994 }, { "a": "AR 16 PA 2 ALN 1 PTA (a)", "b": "AR 16 PA 2 ALN 1 PTA (a)", "ratio": 0.978 }, { "a": "AR 16 PA 2 ALN 1 PTA (b)", "b": "AR 16 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 16 PA 3", "b": "AR 16 PA 3", "ratio": 1.0 }, { "a": "AR 16 PA 3 ALN 1", "b": "AR 16 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 16 PA 3 ALN 2", "b": "AR 16 PA 3 ALN 2", "ratio": 1.0 }, { "a": "AR 16 PA 4", "b": "AR 16 PA 4", "ratio": 0.988 }, { "a": "AR 16 PA 4 ALN 1", "b": "AR 16 PA 4 ALN 1", "ratio": 0.988 } ], "passages": [ { "a": "the market a device under its name, registered trade name or registered", "b": "the market a device under its own name, registered trade name or registered", "cut": false }, { "a": "a manufacturer as defined in point (30) of Article 2, assembles or adapts", "b": "a manufacturer as defined in point (23) of Article 2, assembles or adapts", "cut": false }, { "a": "the manufacturer, in accordance with Section 23 of Annex I, relating to a", "b": "the manufacturer, in accordance with Section 20 of Annex I, relating to a", "cut": false }, { "a": "carrying out any of the activities mentioned in points (a) and (b) of", "b": "carrying out any of the activities referred to in points (a) and (b) of", "cut": false }, { "a": "competent authority with a sample or mock-up of the relabelled or repackaged", "b": "competent authority with a sample or a mock-up of the relabelled or repackaged", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 19", "b": "AR 17", "ratio": 0.968, "identical": false, "numbering_only": false, "children": [ { "a": "AR 19 PA 1", "b": "AR 17 PA 1", "ratio": 0.931 }, { "a": "AR 19 PA 1 ALN 1", "b": "AR 17 PA 1 ALN 1", "ratio": 0.93 }, { "a": "AR 19 PA 2", "b": "AR 17 PA 2", "ratio": 1.0 }, { "a": "AR 19 PA 2 ALN 1", "b": "AR 17 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 19 PA 3", "b": "AR 17 PA 3", "ratio": 1.0 }, { "a": "AR 19 PA 3 ALN 1", "b": "AR 17 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 19 PA 4", "b": "AR 17 PA 4", "ratio": 0.971 }, { "a": "AR 19 PA 4 ALN 1", "b": "AR 17 PA 4 ALN 1", "ratio": 0.971 } ], "passages": [ { "a": "Article 19 EU declaration of conformity 1. The", "b": "Article 17 EU declaration of conformity 1. The", "cut": false }, { "a": "specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the", "b": "specified in this Regulation have been fulfilled. The manufacturer shall continuously update the", "cut": false }, { "a": "delegated acts in accordance with Article 115 amending the minimum content of the", "b": "delegated acts in accordance with Article 108 amending the minimum content of the", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 20", "b": "AR 18", "ratio": 0.974, "identical": false, "numbering_only": false, "children": [ { "a": "AR 20 PA 2", "b": "AR 18 PA 2", "ratio": 1.0 }, { "a": "AR 20 PA 2 ALN 1", "b": "AR 18 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 20 PA 3", "b": "AR 18 PA 3", "ratio": 1.0 }, { "a": "AR 20 PA 3 ALN 1", "b": "AR 18 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 20 PA 4", "b": "AR 18 PA 4", "ratio": 1.0 }, { "a": "AR 20 PA 4 ALN 1", "b": "AR 18 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 20 PA 5", "b": "AR 18 PA 5", "ratio": 0.98 }, { "a": "AR 20 PA 5 ALN 1", "b": "AR 18 PA 5 ALN 1", "ratio": 0.98 }, { "a": "AR 20 PA 6", "b": "AR 18 PA 6", "ratio": 1.0 }, { "a": "AR 20 PA 6 ALN 1", "b": "AR 18 PA 6 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 20 CE marking of conformity 1. Devices,", "b": "Article 18 CE marking of conformity 1. Devices,", "cut": false }, { "a": "of conformity 1. Devices, other than custom-made or investigational devices, considered to be in conformity with", "b": "of conformity 1. Devices, other than devices for performance studies, considered to be in conformity with", "cut": false }, { "a": "assessment procedures set out in Article 52. The identification number shall also be", "b": "assessment procedures set out in Article 48. The identification number shall also be", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 23", "b": "AR 20", "ratio": 0.993, "identical": false, "numbering_only": true, "children": [ { "a": "AR 23 PA 1", "b": "AR 20 PA 1", "ratio": 1.0 }, { "a": "AR 23 PA 1 ALN 1", "b": "AR 20 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 23 PA 2", "b": "AR 20 PA 2", "ratio": 1.0 }, { "a": "AR 23 PA 2 ALN 1", "b": "AR 20 PA 2 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 23 Parts and components 1. Any natural", "b": "Article 20 Parts and components 1. Any natural", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 24", "b": "AR 21", "ratio": 0.977, "identical": false, "numbering_only": true, "children": [ { "a": "AR 24 ALN 1", "b": "AR 21 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 24 Free movement Except where otherwise provided", "b": "Article 21 Free movement Except where otherwise provided", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 25", "b": "AR 22", "ratio": 0.977, "identical": false, "numbering_only": true, "children": [ { "a": "AR 25 PA 1", "b": "AR 22 PA 1", "ratio": 1.0 }, { "a": "AR 25 PA 1 ALN 1", "b": "AR 22 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 25 PA 2", "b": "AR 22 PA 2", "ratio": 0.984 }, { "a": "AR 25 PA 2 ALN 1", "b": "AR 22 PA 2 ALN 1", "ratio": 0.983 }, { "a": "AR 25 PA 2 ALN 1 PTA (a)", "b": "AR 22 PA 2 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 25 PA 2 ALN 1 PTA (b)", "b": "AR 22 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 25 PA 2 ALN 1 PTA (c)", "b": "AR 22 PA 2 ALN 1 PTA (c)", "ratio": 1.0 } ], "passages": [ { "a": "Article 25 Identification within the supply chain 1.", "b": "Article 22 Identification within the supply chain 1.", "cut": false }, { "a": "the period referred to in Article 10(8): (a) any economic operator to whom", "b": "the period referred to in Article 10(7): (a) any economic operator to whom", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 26", "b": "AR 23", "ratio": 0.924, "identical": false, "numbering_only": false, "children": [ { "a": "AR 26 ALN 1", "b": "AR 23 ALN 1", "ratio": 0.932 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 27", "b": "AR 24", "ratio": 0.939, "identical": false, "numbering_only": false, "children": [ { "a": "AR 27 PA 1", "b": "AR 24 PA 1", "ratio": 0.95 }, { "a": "AR 27 PA 1 ALN 1", "b": "AR 24 PA 1 ALN 1", "ratio": 0.949 }, { "a": "AR 27 PA 1 ALN 1 PTA (a)", "b": "AR 24 PA 1 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 27 PA 1 ALN 1 PTA (a) PTI (i)", "b": "AR 24 PA 1 ALN 1 PTA (a) PTI (i)", "ratio": 1.0 }, { "a": "AR 27 PA 1 ALN 1 PTA (a) PTI (ii)", "b": "AR 24 PA 1 ALN 1 PTA (a) PTI (ii)", "ratio": 1.0 }, { "a": "AR 27 PA 1 ALN 1 PTA (b)", "b": "AR 24 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 27 PA 1 ALN 1 PTA (c)", "b": "AR 24 PA 1 ALN 1 PTA (c)", "ratio": 0.945 }, { "a": "AR 27 PA 2", "b": "AR 24 PA 2", "ratio": 0.983 }, { "a": "AR 27 PA 2 ALN 1", "b": "AR 24 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (a)", "b": "AR 24 PA 2 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (b)", "b": "AR 24 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (c)", "b": "AR 24 PA 2 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (d)", "b": "AR 24 PA 2 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (e)", "b": "AR 24 PA 2 ALN 1 PTA (e)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (e) PTI (i)", "b": "AR 24 PA 2 ALN 1 PTA (e) PTI (i)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (e) PTI (ii)", "b": "AR 24 PA 2 ALN 1 PTA (e) PTI (ii)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 1 PTA (e) PTI (iii)", "b": "AR 24 PA 2 ALN 1 PTA (e) PTI (iii)", "ratio": 1.0 }, { "a": "AR 27 PA 2 ALN 2", "b": "AR 24 PA 2 ALN 2", "ratio": 0.918 }, { "a": "AR 27 PA 3", "b": "AR 24 PA 3", "ratio": 0.9 }, { "a": "AR 27 PA 3 ALN 1", "b": "AR 24 PA 3 ALN 1", "ratio": 0.94 }, { "a": "AR 27 PA 4", "b": "AR 24 PA 4", "ratio": 1.0 }, { "a": "AR 27 PA 4 ALN 1", "b": "AR 24 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 27 PA 5", "b": "AR 24 PA 5", "ratio": 0.95 }, { "a": "AR 27 PA 5 ALN 1", "b": "AR 24 PA 5 ALN 1", "ratio": 0.947 }, { "a": "AR 27 PA 6", "b": "AR 24 PA 6", "ratio": 0.929 }, { "a": "AR 27 PA 6 ALN 1", "b": "AR 24 PA 6 ALN 1", "ratio": 0.926 }, { "a": "AR 27 PA 7", "b": "AR 24 PA 7", "ratio": 1.0 }, { "a": "AR 27 PA 7 ALN 1", "b": "AR 24 PA 7 ALN 1", "ratio": 1.0 }, { "a": "AR 27 PA 8", "b": "AR 24 PA 8", "ratio": 0.943 }, { "a": "AR 27 PA 8 ALN 1", "b": "AR 24 PA 8 ALN 1", "ratio": 0.942 }, { "a": "AR 27 PA 10", "b": "AR 24 PA 10", "ratio": 0.982 }, { "a": "AR 27 PA 10 ALN 1", "b": "AR 24 PA 10 ALN 1", "ratio": 0.981 }, { "a": "AR 27 PA 10 ALN 1 PTA (a)", "b": "AR 24 PA 10 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 27 PA 10 ALN 1 PTA (b)", "b": "AR 24 PA 10 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 27 PA 11", "b": "AR 24 PA 11", "ratio": 0.979 }, { "a": "AR 27 PA 11 ALN 1", "b": "AR 24 PA 11 ALN 1", "ratio": 0.986 }, { "a": "AR 27 PA 11 ALN 1 PTA (a)", "b": "AR 24 PA 11 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 27 PA 11 ALN 1 PTA (b)", "b": "AR 24 PA 11 ALN 1 PTA (b)", "ratio": 0.938 }, { "a": "AR 27 PA 11 ALN 2", "b": "AR 24 PA 11 ALN 2", "ratio": 0.957 }, { "a": "AR 27 PA 12", "b": "AR 24 PA 12", "ratio": 0.961 }, { "a": "AR 27 PA 12 ALN 1", "b": "AR 24 PA 12 ALN 1", "ratio": 0.961 }, { "a": "AR 27 PA 12 ALN 1 PTA (b)", "b": "AR 24 PA 12 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 27 PA 12 ALN 1 PTA (c)", "b": "AR 24 PA 12 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 27 PA 12 ALN 1 PTA (d)", "b": "AR 24 PA 12 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 27 PA 12 ALN 1 PTA (e)", "b": "AR 24 PA 12 ALN 1 PTA (e)", "ratio": 1.0 }, { "a": "AR 27 PA 12 ALN 1 PTA (f)", "b": "AR 24 PA 12 ALN 1 PTA (f)", "ratio": 0.943 } ], "passages": [ { "a": "Article 27 Unique Device Identification system 1. The", "b": "Article 24 Unique Device Identification system 1. The", "cut": false }, { "a": "the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:", "b": "the traceability of devices, other than devices for performance studies, and shall consist of the following:", "cut": false }, { "a": "down in paragraphs 8 and 9 of this Article respectively; (d) establishment of an electronic", "b": "down in paragraphs 8 and 9 respectively; (d) establishment of an electronic", "cut": false }, { "a": "database ) in accordance with Article 28. 2. The Commission shall, by means", "b": "database ) in accordance with Article 28 of Regulation (EU) 2017/745. 2. The Commission shall, by means", "cut": false }, { "a": "financial and administrative burdens for economic operators and health institutions. 3. Before placing", "b": "financial and administrative burdens for economic operators, health institutions and healthcare professionals. 3. Before placing", "cut": false }, { "a": "administrative burdens for economic operators and health institutions. 3. Before placing a device, other", "b": "for economic operators, health institutions and healthcare professionals. 3. Before placing a device, other", "cut": false }, { "a": "placing a device, other than a custom-made device, on the market, the manufacturer shall", "b": "placing a device, other than a device for performance study, on the market, the manufacturer shall", "cut": false }, { "a": "Before a device, other than a custom-made or investigational device, is placed on the market the", "b": "Before a device, other than a device for performance study, is placed on the market the", "cut": false }, { "a": "placed on the market the manufacturer shall ensure that the information referred to", "b": "placed on the market the manufacturer must ensure that the information referred to", "cut": false }, { "a": "to in Part B of Annex VI of the device in question are", "b": "to in Part B of Annex V of the device in question are", "cut": false }, { "a": "UDI database referred to in Article 28. 4. UDI carriers shall be placed", "b": "UDI database referred to in Article 25. 4. UDI carriers shall be placed", "cut": false }, { "a": "corrective actions in accordance with Article 87. 6. The Basic UDI-DI, as defined", "b": "corrective actions in accordance with Article 82. 6. The Basic UDI-DI, as defined", "cut": false } ], "passages_omitted": 12, "passages_withheld": false, "headings_equal": true }, { "a": "AR 30", "b": "AR 27", "ratio": 0.969, "identical": false, "numbering_only": false, "children": [ { "a": "AR 30 PA 1", "b": "AR 27 PA 1", "ratio": 0.987 }, { "a": "AR 30 PA 1 ALN 1", "b": "AR 27 PA 1 ALN 1", "ratio": 0.987 }, { "a": "AR 30 PA 2", "b": "AR 27 PA 2", "ratio": 1.0 }, { "a": "AR 30 PA 2 ALN 1", "b": "AR 27 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 30 PA 3", "b": "AR 27 PA 3", "ratio": 0.95 }, { "a": "AR 30 PA 3 ALN 2", "b": "AR 27 PA 3 ALN 2", "ratio": 1.0 } ], "passages": [ { "a": "Article 30 Electronic system for registration of economic", "b": "Article 27 Electronic system for registration of economic", "cut": false }, { "a": "registration number referred to in Article 31(2) and to collate and process information", "b": "registration number referred to in Article 28(2) and to collate and process information", "cut": false }, { "a": "Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify", "b": "Within two weeks of placing a device on the market, importers shall verify", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 31", "b": "AR 28", "ratio": 0.968, "identical": false, "numbering_only": false, "children": [ { "a": "AR 31 PA 1", "b": "AR 28 PA 1", "ratio": 0.945 }, { "a": "AR 31 PA 1 ALN 1", "b": "AR 28 PA 1 ALN 1", "ratio": 0.944 }, { "a": "AR 31 PA 2", "b": "AR 28 PA 2", "ratio": 0.977 }, { "a": "AR 31 PA 2 ALN 1", "b": "AR 28 PA 2 ALN 1", "ratio": 0.977 }, { "a": "AR 31 PA 3", "b": "AR 28 PA 3", "ratio": 0.966 }, { "a": "AR 31 PA 3 ALN 1", "b": "AR 28 PA 3 ALN 1", "ratio": 0.964 }, { "a": "AR 31 PA 4", "b": "AR 28 PA 4", "ratio": 0.973 }, { "a": "AR 31 PA 4 ALN 1", "b": "AR 28 PA 4 ALN 1", "ratio": 0.972 }, { "a": "AR 31 PA 5", "b": "AR 28 PA 5", "ratio": 1.0 }, { "a": "AR 31 PA 5 ALN 1", "b": "AR 28 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 31 PA 6", "b": "AR 28 PA 6", "ratio": 1.0 }, { "a": "AR 31 PA 6 ALN 1", "b": "AR 28 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 31 PA 7", "b": "AR 28 PA 7", "ratio": 0.962 }, { "a": "AR 31 PA 7 ALN 1", "b": "AR 28 PA 7 ALN 1", "ratio": 0.96 }, { "a": "AR 31 PA 8", "b": "AR 28 PA 8", "ratio": 0.958 }, { "a": "AR 31 PA 8 ALN 1", "b": "AR 28 PA 8 ALN 1", "ratio": 0.957 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 32", "b": "AR 29", "ratio": 0.917, "identical": false, "numbering_only": false, "children": [ { "a": "AR 32 PA 1", "b": "AR 29 PA 1", "ratio": 0.918 }, { "a": "AR 32 PA 1 ALN 2", "b": "AR 29 PA 1 ALN 2", "ratio": 0.986 }, { "a": "AR 32 PA 1 ALN 3", "b": "AR 29 PA 1 ALN 3", "ratio": 0.977 }, { "a": "AR 32 PA 2", "b": "AR 29 PA 2", "ratio": 0.907 }, { "a": "AR 32 PA 2 ALN 1", "b": "AR 29 PA 2 ALN 1", "ratio": 0.906 }, { "a": "AR 32 PA 2 ALN 1 PTA (a)", "b": "AR 29 PA 2 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 32 PA 2 ALN 1 PTA (b)", "b": "AR 29 PA 2 ALN 1 PTA (b)", "ratio": 0.929 }, { "a": "AR 32 PA 2 ALN 1 PTA (c)", "b": "AR 29 PA 2 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 32 PA 2 ALN 1 PTA (g)", "b": "AR 29 PA 2 ALN 1 PTA (g)", "ratio": 1.0 }, { "a": "AR 32 PA 2 ALN 1 PTA (h)", "b": "AR 29 PA 2 ALN 1 PTA (h)", "ratio": 1.0 }, { "a": "AR 32 PA 3", "b": "AR 29 PA 3", "ratio": 0.968 }, { "a": "AR 32 PA 3 ALN 1", "b": "AR 29 PA 3 ALN 1", "ratio": 0.968 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 35", "b": "AR 31", "ratio": 0.981, "identical": false, "numbering_only": false, "children": [ { "a": "AR 35 PA 1", "b": "AR 31 PA 1", "ratio": 0.989 }, { "a": "AR 35 PA 1 ALN 1", "b": "AR 31 PA 1 ALN 1", "ratio": 0.989 }, { "a": "AR 35 PA 2", "b": "AR 31 PA 2", "ratio": 1.0 }, { "a": "AR 35 PA 2 ALN 1", "b": "AR 31 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 3", "b": "AR 31 PA 3", "ratio": 1.0 }, { "a": "AR 35 PA 3 ALN 1", "b": "AR 31 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 4", "b": "AR 31 PA 4", "ratio": 1.0 }, { "a": "AR 35 PA 4 ALN 1", "b": "AR 31 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 5", "b": "AR 31 PA 5", "ratio": 1.0 }, { "a": "AR 35 PA 5 ALN 1", "b": "AR 31 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 6", "b": "AR 31 PA 6", "ratio": 0.952 }, { "a": "AR 35 PA 6 ALN 1", "b": "AR 31 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 6 ALN 2", "b": "AR 31 PA 6 ALN 2", "ratio": 0.921 }, { "a": "AR 35 PA 7", "b": "AR 31 PA 7", "ratio": 1.0 }, { "a": "AR 35 PA 7 ALN 1", "b": "AR 31 PA 7 ALN 1", "ratio": 1.0 }, { "a": "AR 35 PA 8", "b": "AR 31 PA 8", "ratio": 0.914 }, { "a": "AR 35 PA 8 ALN 1", "b": "AR 31 PA 8 ALN 1", "ratio": 0.909 } ], "passages": [ { "a": "Article 35 Authorities responsible for notified bodies 1.", "b": "Article 31 Authorities responsible for notified bodies 1.", "cut": false }, { "a": "this Regulation shall appoint an authority ( authority responsible for notified bodies ),", "b": "this Regulation shall appoint an authority (the authority responsible for notified bodies ),", "cut": false }, { "a": "from the national competent authority for medical devices, it shall ensure that", "b": "from the national competent authority for in vitro diagnostic medical devices, it shall ensure that", "cut": false }, { "a": "that the national authority responsible for medical devices is consulted on relevant", "b": "that the national authority responsible for in vitro diagnostic medical devices is consulted on relevant", "cut": false }, { "a": "for notified bodies shall participate in the peer-review activities provided for in Article", "b": "for notified bodies shall participate in peer-review activities provided for in Article", "cut": false }, { "a": "peer-review activities provided for in Article 48.", "b": "peer-review activities provided for in Article 44.", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 36", "b": "AR 32", "ratio": 0.987, "identical": false, "numbering_only": false, "children": [ { "a": "AR 36 PA 1", "b": "AR 32 PA 1", "ratio": 0.992 }, { "a": "AR 36 PA 1 ALN 1", "b": "AR 32 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 36 PA 1 ALN 2", "b": "AR 32 PA 1 ALN 2", "ratio": 0.982 }, { "a": "AR 36 PA 1 ALN 3", "b": "AR 32 PA 1 ALN 3", "ratio": 1.0 }, { "a": "AR 36 PA 2", "b": "AR 32 PA 2", "ratio": 1.0 }, { "a": "AR 36 PA 2 ALN 1", "b": "AR 32 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 36 PA 3", "b": "AR 32 PA 3", "ratio": 0.981 }, { "a": "AR 36 PA 3 ALN 1", "b": "AR 32 PA 3 ALN 1", "ratio": 0.981 } ], "passages": [ { "a": "Article 36 Requirements relating to notified bodies 1.", "b": "Article 32 Requirements relating to notified bodies 1.", "cut": false }, { "a": "accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise", "b": "accordance with Section 3.1.1 of Annex VII, and personnel with relevant clinical expertise", "cut": false }, { "a": "examination procedure referred to in Article 114(3).", "b": "examination procedure referred to in Article 107(3).", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 37", "b": "AR 33", "ratio": 0.994, "identical": false, "numbering_only": true, "children": [ { "a": "AR 37 PA 1", "b": "AR 33 PA 1", "ratio": 1.0 }, { "a": "AR 37 PA 1 ALN 1", "b": "AR 33 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 37 PA 2", "b": "AR 33 PA 2", "ratio": 1.0 }, { "a": "AR 37 PA 2 ALN 1", "b": "AR 33 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 37 PA 3", "b": "AR 33 PA 3", "ratio": 1.0 }, { "a": "AR 37 PA 3 ALN 1", "b": "AR 33 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 37 PA 4", "b": "AR 33 PA 4", "ratio": 1.0 }, { "a": "AR 37 PA 4 ALN 1", "b": "AR 33 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 37 PA 5", "b": "AR 33 PA 5", "ratio": 1.0 }, { "a": "AR 37 PA 5 ALN 1", "b": "AR 33 PA 5 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 37 Subsidiaries and subcontracting 1. Where a", "b": "Article 33 Subsidiaries and subcontracting 1. Where a", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 38", "b": "AR 34", "ratio": 0.99, "identical": false, "numbering_only": true, "children": [ { "a": "AR 38 PA 1", "b": "AR 34 PA 1", "ratio": 1.0 }, { "a": "AR 38 PA 1 ALN 1", "b": "AR 34 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 38 PA 2", "b": "AR 34 PA 2", "ratio": 0.992 }, { "a": "AR 38 PA 2 ALN 1", "b": "AR 34 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 38 PA 2 ALN 2", "b": "AR 34 PA 2 ALN 2", "ratio": 0.988 }, { "a": "AR 38 PA 3", "b": "AR 34 PA 3", "ratio": 1.0 }, { "a": "AR 38 PA 3 ALN 1", "b": "AR 34 PA 3 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 38 Application by conformity assessment bodies for", "b": "Article 34 Application by conformity assessment bodies for", "cut": false }, { "a": "during the assessment described in Article 39. However, the applicant shall make available", "b": "during the assessment described in Article 35. However, the applicant shall make available", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 39", "b": "AR 35", "ratio": 0.984, "identical": false, "numbering_only": false, "children": [ { "a": "AR 39 PA 1", "b": "AR 35 PA 1", "ratio": 0.979 }, { "a": "AR 39 PA 1 ALN 1", "b": "AR 35 PA 1 ALN 1", "ratio": 0.966 }, { "a": "AR 39 PA 1 ALN 2", "b": "AR 35 PA 1 ALN 2", "ratio": 1.0 }, { "a": "AR 39 PA 2", "b": "AR 35 PA 2", "ratio": 1.0 }, { "a": "AR 39 PA 2 ALN 1", "b": "AR 35 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 39 PA 3", "b": "AR 35 PA 3", "ratio": 0.983 }, { "a": "AR 39 PA 3 ALN 1", "b": "AR 35 PA 3 ALN 1", "ratio": 0.989 }, { "a": "AR 39 PA 3 ALN 2", "b": "AR 35 PA 3 ALN 2", "ratio": 0.972 }, { "a": "AR 39 PA 4", "b": "AR 35 PA 4", "ratio": 0.991 }, { "a": "AR 39 PA 4 ALN 1", "b": "AR 35 PA 4 ALN 1", "ratio": 0.98 }, { "a": "AR 39 PA 4 ALN 2", "b": "AR 35 PA 4 ALN 2", "ratio": 1.0 }, { "a": "AR 39 PA 4 ALN 3", "b": "AR 35 PA 4 ALN 3", "ratio": 1.0 }, { "a": "AR 39 PA 5", "b": "AR 35 PA 5", "ratio": 0.996 }, { "a": "AR 39 PA 5 ALN 1", "b": "AR 35 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 39 PA 5 ALN 2", "b": "AR 35 PA 5 ALN 2", "ratio": 0.986 }, { "a": "AR 39 PA 5 ALN 3", "b": "AR 35 PA 5 ALN 3", "ratio": 1.0 }, { "a": "AR 39 PA 6", "b": "AR 35 PA 6", "ratio": 1.0 }, { "a": "AR 39 PA 6 ALN 1", "b": "AR 35 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 39 PA 7", "b": "AR 35 PA 7", "ratio": 0.973 }, { "a": "AR 39 PA 7 ALN 1", "b": "AR 35 PA 7 ALN 1", "ratio": 0.962 }, { "a": "AR 39 PA 7 ALN 2", "b": "AR 35 PA 7 ALN 2", "ratio": 0.953 }, { "a": "AR 39 PA 7 ALN 3", "b": "AR 35 PA 7 ALN 3", "ratio": 1.0 }, { "a": "AR 39 PA 8", "b": "AR 35 PA 8", "ratio": 1.0 }, { "a": "AR 39 PA 8 ALN 1", "b": "AR 35 PA 8 ALN 1", "ratio": 1.0 }, { "a": "AR 39 PA 9", "b": "AR 35 PA 9", "ratio": 0.99 }, { "a": "AR 39 PA 9 ALN 1", "b": "AR 35 PA 9 ALN 1", "ratio": 0.989 }, { "a": "AR 39 PA 10", "b": "AR 35 PA 10", "ratio": 0.966 }, { "a": "AR 39 PA 10 ALN 1", "b": "AR 35 PA 10 ALN 1", "ratio": 0.965 } ], "passages": [ { "a": "Article 39 Assessment of the application 1. The", "b": "Article 35 Assessment of the application 1. The", "cut": false }, { "a": "the application referred to in Article 38 is complete and shall request the", "b": "the application referred to in Article 34 is complete and shall request the", "cut": false }, { "a": "Once the application is complete that authority shall send it to the", "b": "Once the application is complete that national authority shall send it to the", "cut": false }, { "a": "the list referred to in Article 40(2). One of the experts shall be", "b": "the list referred to in Article 36. One of the experts shall be", "cut": false }, { "a": "assessment team shall be comprised of experts who are competent to assess", "b": "assessment team shall be comprised of competent experts who are competent to assess", "cut": false }, { "a": "is initiated in accordance with Article 47(3), to ensure that the specific concern", "b": "is initiated in accordance with Article 43(3) to ensure that the specific concern", "cut": false }, { "a": "the application in accordance with Article 38. The joint assessment team may provide", "b": "the application in accordance with Article 34. The joint assessment team may provide", "cut": false }, { "a": "resulting from the assessment and summarise the assessment by the joint assessment", "b": "resulting from the assessment and summarise of the assessment by the joint assessment", "cut": false }, { "a": "The authority responsible for notified bodies shall following receipt of a corrective and", "b": "The authority responsible for notified bodies shall, following receipt of a corrective and", "cut": false }, { "a": "preventive action plan from the applicant body assess whether non-compliances identified during the", "b": "preventive action plan from the applicant body, assess whether non-compliances identified during the", "cut": false }, { "a": "The authority responsible for notified bodies shall having confirmed the corrective and preventive", "b": "The authority responsible for notified bodies shall, having confirmed the corrective and preventive", "cut": false }, { "a": "confirmed the corrective and preventive action plan forward it and its opinion thereon", "b": "confirmed the corrective and preventive action plan, forward it and its opinion thereon", "cut": false } ], "passages_omitted": 3, "passages_withheld": false, "headings_equal": true }, { "a": "AR 40", "b": "AR 36", "ratio": 0.944, "identical": false, "numbering_only": false, "children": [ { "a": "AR 40 PA 1", "b": "AR 36 PA 1", "ratio": 0.907 }, { "a": "AR 40 PA 1 ALN 1", "b": "AR 36 PA 1 ALN 1", "ratio": 0.904 }, { "a": "AR 40 PA 2", "b": "AR 36 PA 2", "ratio": 0.98 }, { "a": "AR 40 PA 2 ALN 1", "b": "AR 36 PA 2 ALN 1", "ratio": 0.979 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 41", "b": "AR 37", "ratio": 0.942, "identical": false, "numbering_only": true, "children": [ { "a": "AR 41 ALN 1", "b": "AR 37 ALN 1", "ratio": 0.926 }, { "a": "AR 41 ALN 2", "b": "AR 37 ALN 2", "ratio": 1.0 }, { "a": "AR 41 ALN 3", "b": "AR 37 ALN 3", "ratio": 0.932 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 42", "b": "AR 38", "ratio": 0.981, "identical": false, "numbering_only": false, "children": [ { "a": "AR 42 PA 1", "b": "AR 38 PA 1", "ratio": 0.96 }, { "a": "AR 42 PA 1 ALN 1", "b": "AR 38 PA 1 ALN 1", "ratio": 0.958 }, { "a": "AR 42 PA 2", "b": "AR 38 PA 2", "ratio": 1.0 }, { "a": "AR 42 PA 2 ALN 1", "b": "AR 38 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 3", "b": "AR 38 PA 3", "ratio": 0.965 }, { "a": "AR 42 PA 3 ALN 1", "b": "AR 38 PA 3 ALN 1", "ratio": 0.964 }, { "a": "AR 42 PA 4", "b": "AR 38 PA 4", "ratio": 0.982 }, { "a": "AR 42 PA 4 ALN 1", "b": "AR 38 PA 4 ALN 1", "ratio": 0.982 }, { "a": "AR 42 PA 5", "b": "AR 38 PA 5", "ratio": 0.982 }, { "a": "AR 42 PA 5 ALN 1", "b": "AR 38 PA 5 ALN 1", "ratio": 0.982 }, { "a": "AR 42 PA 6", "b": "AR 38 PA 6", "ratio": 1.0 }, { "a": "AR 42 PA 6 ALN 1", "b": "AR 38 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 7", "b": "AR 38 PA 7", "ratio": 1.0 }, { "a": "AR 42 PA 7 ALN 1", "b": "AR 38 PA 7 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 8", "b": "AR 38 PA 8", "ratio": 1.0 }, { "a": "AR 42 PA 8 ALN 1", "b": "AR 38 PA 8 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 9", "b": "AR 38 PA 9", "ratio": 1.0 }, { "a": "AR 42 PA 9 ALN 1", "b": "AR 38 PA 9 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 10", "b": "AR 38 PA 10", "ratio": 0.956 }, { "a": "AR 42 PA 10 ALN 1", "b": "AR 38 PA 10 ALN 1", "ratio": 0.955 }, { "a": "AR 42 PA 11", "b": "AR 38 PA 11", "ratio": 1.0 }, { "a": "AR 42 PA 11 ALN 1", "b": "AR 38 PA 11 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 12", "b": "AR 38 PA 12", "ratio": 1.0 }, { "a": "AR 42 PA 12 ALN 1", "b": "AR 38 PA 12 ALN 1", "ratio": 1.0 }, { "a": "AR 42 PA 13", "b": "AR 38 PA 13", "ratio": 0.943 }, { "a": "AR 42 PA 13 ALN 1", "b": "AR 38 PA 13 ALN 1", "ratio": 0.955 } ], "passages": [ { "a": "Article 42 Designation and notification procedure 1. Member", "b": "Article 38 Designation and notification procedure 1. Member", "cut": false }, { "a": "which the assessment pursuant to Article 39 was completed and which comply with", "b": "which the assessment pursuant to Article 35 was completed and which comply with", "cut": false }, { "a": "assessment activities as defined in this Regulation and the types of devices which", "b": "assessment activities as defined in this Regulation, and the types of devices which", "cut": false }, { "a": "assess and, without prejudice to Article 44, any conditions associated with the designation.", "b": "assess and, without prejudice to Article 40, any conditions associated with the designation.", "cut": false }, { "a": "assessment team referred to in Article 39(9) and the recommendation of the MDCG.", "b": "assessment team referred to in Article 35(9) and the recommendation of the MDCG.", "cut": false }, { "a": "State shall, without prejudice to Article 44, inform the Commission and the other", "b": "State shall, without prejudice to Article 40, inform the Commission and the other", "cut": false }, { "a": "notification in NANDO, the Commission shall also add to the electronic system referred", "b": "notification in NANDO, the Commission shall add to the electronic system referred", "cut": false }, { "a": "electronic system referred to in Article 57 the information relating to the notification", "b": "electronic system referred to in Article 52 the information relating to the notification", "cut": false }, { "a": "this Article and the opinion and responses referred to in paragraphs 7 and", "b": "this Article and the opinion and response referred to in paragraphs 7 and", "cut": false }, { "a": "valid in accordance with paragraph 11. 13. The Commission shall by 26 November", "b": "valid in accordance with paragraph 11. 13 The Commission shall by 26 November", "cut": false }, { "a": "examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG,", "b": "examination procedure referred to in Article 107(3). The Commission, after consulting the MDCG,", "cut": false }, { "a": "may update this list based, inter alia , on information arising from the coordination", "b": "may update this list based, inter alia, on information arising from the coordination", "cut": false } ], "passages_omitted": 1, "passages_withheld": false, "headings_equal": true }, { "a": "AR 43", "b": "AR 39", "ratio": 0.949, "identical": false, "numbering_only": false, "children": [ { "a": "AR 43 PA 1", "b": "AR 39 PA 1", "ratio": 0.913 }, { "a": "AR 43 PA 1 ALN 1", "b": "AR 39 PA 1 ALN 1", "ratio": 0.912 }, { "a": "AR 43 PA 2", "b": "AR 39 PA 2", "ratio": 0.987 }, { "a": "AR 43 PA 2 ALN 1", "b": "AR 39 PA 2 ALN 1", "ratio": 0.987 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 44", "b": "AR 40", "ratio": 0.988, "identical": false, "numbering_only": false, "children": [ { "a": "AR 44 PA 1", "b": "AR 40 PA 1", "ratio": 1.0 }, { "a": "AR 44 PA 1 ALN 1", "b": "AR 40 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 2", "b": "AR 40 PA 2", "ratio": 1.0 }, { "a": "AR 44 PA 2 ALN 1", "b": "AR 40 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 3", "b": "AR 40 PA 3", "ratio": 1.0 }, { "a": "AR 44 PA 3 ALN 1", "b": "AR 40 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 4", "b": "AR 40 PA 4", "ratio": 1.0 }, { "a": "AR 44 PA 4 ALN 1", "b": "AR 40 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 4 ALN 2", "b": "AR 40 PA 4 ALN 2", "ratio": 1.0 }, { "a": "AR 44 PA 5", "b": "AR 40 PA 5", "ratio": 0.989 }, { "a": "AR 44 PA 5 ALN 1", "b": "AR 40 PA 5 ALN 1", "ratio": 0.989 }, { "a": "AR 44 PA 6", "b": "AR 40 PA 6", "ratio": 1.0 }, { "a": "AR 44 PA 6 ALN 1", "b": "AR 40 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 6 ALN 2", "b": "AR 40 PA 6 ALN 2", "ratio": 1.0 }, { "a": "AR 44 PA 7", "b": "AR 40 PA 7", "ratio": 1.0 }, { "a": "AR 44 PA 7 ALN 1", "b": "AR 40 PA 7 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 8", "b": "AR 40 PA 8", "ratio": 0.933 }, { "a": "AR 44 PA 8 ALN 1", "b": "AR 40 PA 8 ALN 1", "ratio": 0.931 }, { "a": "AR 44 PA 9", "b": "AR 40 PA 9", "ratio": 1.0 }, { "a": "AR 44 PA 9 ALN 1", "b": "AR 40 PA 9 ALN 1", "ratio": 1.0 }, { "a": "AR 44 PA 10", "b": "AR 40 PA 10", "ratio": 0.984 }, { "a": "AR 44 PA 10 ALN 1", "b": "AR 40 PA 10 ALN 1", "ratio": 0.985 }, { "a": "AR 44 PA 10 ALN 2", "b": "AR 40 PA 10 ALN 2", "ratio": 0.974 }, { "a": "AR 44 PA 10 ALN 3", "b": "AR 40 PA 10 ALN 3", "ratio": 0.99 }, { "a": "AR 44 PA 11", "b": "AR 40 PA 11", "ratio": 0.938 }, { "a": "AR 44 PA 11 ALN 1", "b": "AR 40 PA 11 ALN 1", "ratio": 0.937 }, { "a": "AR 44 PA 12", "b": "AR 40 PA 12", "ratio": 0.978 }, { "a": "AR 44 PA 12 ALN 1", "b": "AR 40 PA 12 ALN 1", "ratio": 0.986 }, { "a": "AR 44 PA 12 ALN 2", "b": "AR 40 PA 12 ALN 2", "ratio": 0.941 } ], "passages": [ { "a": "Article 44 Monitoring and re-assessment of notified bodies", "b": "Article 40 Monitoring and re-assessment of notified bodies", "cut": false }, { "a": "subsidiaries and subcontractors, as that personnel is in the process of conducting quality", "b": "subsidiaries and subcontractors, as that personnel in the process of conducting quality", "cut": false }, { "a": "manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in", "b": "manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in", "cut": false }, { "a": "documentation as further outlined in Article 45. 9. The authority responsible for notified", "b": "documentation as further outlined in Article 41. 9. The authority responsible for notified", "cut": false }, { "a": "with the procedure described in Article 39. The authority responsible for notified bodies", "b": "with the procedure described in Article 35. The authority responsible for notified bodies", "cut": false }, { "a": "dates referred to in the first subparagraph, upon request by the notified body", "b": "dates referred to in the first subparagraph upon request by the notified body", "cut": false }, { "a": "the results of the annual assessments conducted in accordance with paragraph 4 of", "b": "the results of the annual assessments performed in accordance with paragraph 4 of", "cut": false }, { "a": "suspend or terminate the ongoing complete re-assessment, taking into account its own resources", "b": "suspend or terminate the ongoing complete re-assessment taking into account its own resources", "cut": false }, { "a": "delegated acts in accordance with Article 115 in order to amend paragraph 10", "b": "delegated acts in accordance with Article 108 in order to amend paragraph 10", "cut": false }, { "a": "in order to amend paragraph 10 to modify the frequency at which", "b": "in order to amend paragraph 10 of this Article to modify the frequency at which", "cut": false }, { "a": "by the MDCG and the Commission; however it shall contain a summary which", "b": "by the MDCG and the Commission; however, it shall contain a summary which", "cut": false }, { "a": "electronic system referred to in Article 57.", "b": "electronic system referred to in Article 52.", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 45", "b": "AR 41", "ratio": 0.953, "identical": false, "numbering_only": false, "children": [ { "a": "AR 45 PA 2", "b": "AR 41 PA 2", "ratio": 1.0 }, { "a": "AR 45 PA 2 ALN 1", "b": "AR 41 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 45 PA 3", "b": "AR 41 PA 3", "ratio": 0.985 }, { "a": "AR 45 PA 3 ALN 1", "b": "AR 41 PA 3 ALN 1", "ratio": 0.984 }, { "a": "AR 45 PA 4", "b": "AR 41 PA 4", "ratio": 0.944 }, { "a": "AR 45 PA 4 ALN 1", "b": "AR 41 PA 4 ALN 1", "ratio": 0.943 }, { "a": "AR 45 PA 5", "b": "AR 41 PA 5", "ratio": 0.961 }, { "a": "AR 45 PA 5 ALN 1", "b": "AR 41 PA 5 ALN 1", "ratio": 0.961 }, { "a": "AR 45 PA 6", "b": "AR 41 PA 6", "ratio": 0.964 }, { "a": "AR 45 PA 6 ALN 1", "b": "AR 41 PA 6 ALN 1", "ratio": 0.964 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 46", "b": "AR 42", "ratio": 0.983, "identical": false, "numbering_only": false, "children": [ { "a": "AR 46 PA 1", "b": "AR 42 PA 1", "ratio": 0.971 }, { "a": "AR 46 PA 1 ALN 1", "b": "AR 42 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 46 PA 1 ALN 2", "b": "AR 42 PA 1 ALN 2", "ratio": 0.9 }, { "a": "AR 46 PA 1 ALN 3", "b": "AR 42 PA 1 ALN 3", "ratio": 1.0 }, { "a": "AR 46 PA 2", "b": "AR 42 PA 2", "ratio": 0.972 }, { "a": "AR 46 PA 2 ALN 1", "b": "AR 42 PA 2 ALN 1", "ratio": 0.971 }, { "a": "AR 46 PA 3", "b": "AR 42 PA 3", "ratio": 1.0 }, { "a": "AR 46 PA 3 ALN 1", "b": "AR 42 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 46 PA 4", "b": "AR 42 PA 4", "ratio": 1.0 }, { "a": "AR 46 PA 4 ALN 1", "b": "AR 42 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 46 PA 4 ALN 2", "b": "AR 42 PA 4 ALN 2", "ratio": 1.0 }, { "a": "AR 46 PA 5", "b": "AR 42 PA 5", "ratio": 1.0 }, { "a": "AR 46 PA 5 ALN 1", "b": "AR 42 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 46 PA 6", "b": "AR 42 PA 6", "ratio": 1.0 }, { "a": "AR 46 PA 6 ALN 1", "b": "AR 42 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 46 PA 7", "b": "AR 42 PA 7", "ratio": 0.97 }, { "a": "AR 46 PA 7 ALN 1", "b": "AR 42 PA 7 ALN 1", "ratio": 0.975 }, { "a": "AR 46 PA 7 ALN 1 PTA (a)", "b": "AR 42 PA 7 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 46 PA 7 ALN 1 PTA (b)", "b": "AR 42 PA 7 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 46 PA 7 ALN 1 PTA (c)", "b": "AR 42 PA 7 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 46 PA 7 ALN 1 PTA (d)", "b": "AR 42 PA 7 ALN 1 PTA (d)", "ratio": 0.92 }, { "a": "AR 46 PA 7 ALN 1 PTA (e)", "b": "AR 42 PA 7 ALN 1 PTA (e)", "ratio": 0.964 }, { "a": "AR 46 PA 8", "b": "AR 42 PA 8", "ratio": 0.981 }, { "a": "AR 46 PA 8 ALN 1", "b": "AR 42 PA 8 ALN 1", "ratio": 0.981 }, { "a": "AR 46 PA 8 ALN 1 PTA (a)", "b": "AR 42 PA 8 ALN 1 PTA (a)", "ratio": 0.981 }, { "a": "AR 46 PA 8 ALN 1 PTA (b)", "b": "AR 42 PA 8 ALN 1 PTA (b)", "ratio": 0.978 }, { "a": "AR 46 PA 9", "b": "AR 42 PA 9", "ratio": 0.98 }, { "a": "AR 46 PA 9 ALN 1", "b": "AR 42 PA 9 ALN 1", "ratio": 0.986 }, { "a": "AR 46 PA 9 ALN 1 PTA (a)", "b": "AR 42 PA 9 ALN 1 PTA (a)", "ratio": 0.967 }, { "a": "AR 46 PA 9 ALN 1 PTA (b)", "b": "AR 42 PA 9 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 46 PA 9 ALN 2", "b": "AR 42 PA 9 ALN 2", "ratio": 0.957 }, { "a": "AR 46 PA 9 ALN 3", "b": "AR 42 PA 9 ALN 3", "ratio": 1.0 } ], "passages": [ { "a": "Article 46 Changes to designations and notifications 1.", "b": "Article 42 Changes to designations and notifications 1.", "cut": false }, { "a": "body. The procedures described in Article 39 and in Article 42 shall apply", "b": "body. The procedures described in Article 35 and in Article 38 shall apply", "cut": false }, { "a": "in Article 39 and in Article 42 shall apply to extensions of the", "b": "in Article 35 and in Article 38 shall apply to extensions of the", "cut": false }, { "a": "electronic system referred to in Article 57. 3. Where a notified body decides", "b": "electronic system referred to in Article 52. 3. Where a notified body decides", "cut": false }, { "a": "for market surveillance at their request. 7. In the event of restriction, suspension", "b": "for market surveillance at their request. 7 In the event of restriction, suspension", "cut": false }, { "a": "devices on the market; (d) enter into the electronic system referred to in", "b": "devices on the market; (d) enter in the electronic system referred to in", "cut": false }, { "a": "electronic system referred to in Article 57 information in relation to certificates of", "b": "electronic system referred to in Article 52 information in relation to certificates of", "cut": false }, { "a": "(e) inform the competent authority for medical devices of the Member State", "b": "(e) inform the competent authority for in vitro diagnostic medical devices of the Member State", "cut": false }, { "a": "electronic system referred to in Article 57 of the certificates for which it", "b": "electronic system referred to in Article 52 of the certificates for which it", "cut": false }, { "a": "certificates affected by the suspension or restriction, and the authority responsible for notified", "b": "certificates affected by the suspension or restriction and the authority responsible for notified", "cut": false }, { "a": "has the capability of continuing to monitor and remain responsible for existing certificates", "b": "has the capability of continuing to monitor, and remain responsible for, existing certificates", "cut": false }, { "a": "continuing to monitor and remain responsible for existing certificates issued for the period", "b": "continuing to monitor, and remain responsible for, existing certificates issued for the period", "cut": false } ], "passages_omitted": 5, "passages_withheld": false, "headings_equal": true }, { "a": "AR 47", "b": "AR 43", "ratio": 0.976, "identical": false, "numbering_only": false, "children": [ { "a": "AR 47 PA 1", "b": "AR 43 PA 1", "ratio": 1.0 }, { "a": "AR 47 PA 1 ALN 1", "b": "AR 43 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 47 PA 2", "b": "AR 43 PA 2", "ratio": 1.0 }, { "a": "AR 47 PA 2 ALN 1", "b": "AR 43 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 47 PA 3", "b": "AR 43 PA 3", "ratio": 0.961 }, { "a": "AR 47 PA 3 ALN 1", "b": "AR 43 PA 3 ALN 1", "ratio": 0.96 }, { "a": "AR 47 PA 4", "b": "AR 43 PA 4", "ratio": 0.982 }, { "a": "AR 47 PA 4 ALN 1", "b": "AR 43 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 47 PA 4 ALN 2", "b": "AR 43 PA 4 ALN 2", "ratio": 0.969 }, { "a": "AR 47 PA 5", "b": "AR 43 PA 5", "ratio": 1.0 }, { "a": "AR 47 PA 5 ALN 1", "b": "AR 43 PA 5 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 47 Challenge to the competence of notified", "b": "Article 43 Challenge to the competence of notified", "cut": false }, { "a": "the assessment procedure described in Article 39(3) and (4), where there is reasonable", "b": "the assessment procedure described in Article 35(3) and (5) where there is reasonable", "cut": false }, { "a": "procedure described in Article 39(3) and (4), where there is reasonable concern about", "b": "procedure described in Article 35(3) and (5) where there is reasonable concern about", "cut": false }, { "a": "shall follow the principles of Article 39. Alternatively, depending on the severity of", "b": "shall follow the principles of Article 35. Alternatively, depending on the severity of", "cut": false }, { "a": "the list established pursuant to Article 40 in an on-site assessment as part", "b": "the list established pursuant to Article 36 in an on-site assessment as part", "cut": false }, { "a": "assessment activities in accordance with Article 44 and as outlined in the annual", "b": "assessment activities in accordance with Article 40 and as outlined in the annual", "cut": false }, { "a": "annual assessment plan described in Article 44(4). 4. Where the Commission ascertains that", "b": "annual assessment plan described in Article 40(4) therein. 4. Where the Commission ascertains that", "cut": false }, { "a": "examination procedure referred to in Article 114(3). It shall notify the Member State", "b": "examination procedure referred to in Article 107(3). It shall notify the Member State", "cut": false }, { "a": "electronic system referred to in Article 57. 5. The Commission shall ensure that", "b": "electronic system referred to in Article 52. 5. The Commission shall ensure that", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 48", "b": "AR 44", "ratio": 0.971, "identical": false, "numbering_only": false, "children": [ { "a": "AR 48 PA 1", "b": "AR 44 PA 1", "ratio": 0.98 }, { "a": "AR 48 PA 1 ALN 1", "b": "AR 44 PA 1 ALN 1", "ratio": 0.979 }, { "a": "AR 48 PA 1 ALN 1 PTA (a)", "b": "AR 44 PA 1 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 48 PA 1 ALN 1 PTA (b)", "b": "AR 44 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 48 PA 1 ALN 1 PTA (c)", "b": "AR 44 PA 1 ALN 1 PTA (c)", "ratio": 0.917 }, { "a": "AR 48 PA 1 ALN 1 PTA (d)", "b": "AR 44 PA 1 ALN 1 PTA (d)", "ratio": 0.957 }, { "a": "AR 48 PA 1 ALN 1 PTA (e)", "b": "AR 44 PA 1 ALN 1 PTA (e)", "ratio": 0.933 }, { "a": "AR 48 PA 1 ALN 1 PTA (f)", "b": "AR 44 PA 1 ALN 1 PTA (f)", "ratio": 1.0 }, { "a": "AR 48 PA 1 ALN 1 PTA (g)", "b": "AR 44 PA 1 ALN 1 PTA (g)", "ratio": 1.0 }, { "a": "AR 48 PA 2", "b": "AR 44 PA 2", "ratio": 0.949 }, { "a": "AR 48 PA 2 ALN 1", "b": "AR 44 PA 2 ALN 1", "ratio": 0.948 }, { "a": "AR 48 PA 3", "b": "AR 44 PA 3", "ratio": 1.0 }, { "a": "AR 48 PA 3 ALN 1", "b": "AR 44 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 48 PA 4", "b": "AR 44 PA 4", "ratio": 1.0 }, { "a": "AR 48 PA 4 ALN 1", "b": "AR 44 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 48 PA 5", "b": "AR 44 PA 5", "ratio": 0.963 }, { "a": "AR 48 PA 5 ALN 1", "b": "AR 44 PA 5 ALN 1", "ratio": 0.962 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 50", "b": "AR 46", "ratio": 0.968, "identical": false, "numbering_only": true, "children": [ { "a": "AR 50 ALN 1", "b": "AR 46 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 50 List of standard fees Notified bodies", "b": "Article 46 List of standard fees Notified bodies", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 51", "b": "AR 47", "ratio": 0.981, "identical": false, "numbering_only": false, "children": [ { "a": "AR 51 PA 2", "b": "AR 47 PA 2", "ratio": 0.994 }, { "a": "AR 51 PA 2 ALN 1", "b": "AR 47 PA 2 ALN 1", "ratio": 0.993 }, { "a": "AR 51 PA 2 ALN 2", "b": "AR 47 PA 2 ALN 2", "ratio": 1.0 }, { "a": "AR 51 PA 3", "b": "AR 47 PA 3", "ratio": 0.99 }, { "a": "AR 51 PA 3 ALN 1", "b": "AR 47 PA 3 ALN 1", "ratio": 0.99 }, { "a": "AR 51 PA 3 ALN 1 PTA (a)", "b": "AR 47 PA 3 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 51 PA 3 ALN 1 PTA (b)", "b": "AR 47 PA 3 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 51 PA 4", "b": "AR 47 PA 4", "ratio": 1.0 }, { "a": "AR 51 PA 4 ALN 1", "b": "AR 47 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 51 PA 5", "b": "AR 47 PA 5", "ratio": 1.0 }, { "a": "AR 51 PA 5 ALN 1", "b": "AR 47 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 51 PA 6", "b": "AR 47 PA 6", "ratio": 0.966 }, { "a": "AR 51 PA 6 ALN 1", "b": "AR 47 PA 6 ALN 1", "ratio": 0.964 } ], "passages": [ { "a": "Article 51 Classification of devices 1. Devices shall", "b": "Article 47 Classification of devices 1. Devices shall", "cut": false }, { "a": "Devices shall be divided into classes I, IIa, IIb and III, taking into account the", "b": "Devices shall be divided into classes A, B, C and D, taking into account the", "cut": false }, { "a": "into classes I, IIa, IIb and III, taking into account the intended purpose", "b": "into classes A, B, C and D, taking into account the intended purpose", "cut": false }, { "a": "of the second paragraph of Section 2.2 of Annex IX has its registered", "b": "of the second paragraph of Section 2.2. of Annex IX has its registered", "cut": false }, { "a": "At the request of a Member State the Commission shall after consulting the", "b": "At the request of a Member State, the Commission shall after consulting the", "cut": false }, { "a": "examination procedure referred to in Article 114(3).", "b": "examination procedure referred to in Article 107(3).", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 53", "b": "AR 49", "ratio": 0.992, "identical": false, "numbering_only": true, "children": [ { "a": "AR 53 PA 1", "b": "AR 49 PA 1", "ratio": 1.0 }, { "a": "AR 53 PA 1 ALN 1", "b": "AR 49 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 53 PA 2", "b": "AR 49 PA 2", "ratio": 0.974 }, { "a": "AR 53 PA 2 ALN 1", "b": "AR 49 PA 2 ALN 1", "ratio": 0.974 }, { "a": "AR 53 PA 3", "b": "AR 49 PA 3", "ratio": 1.0 }, { "a": "AR 53 PA 3 ALN 1", "b": "AR 49 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 53 PA 4", "b": "AR 49 PA 4", "ratio": 1.0 }, { "a": "AR 53 PA 4 ALN 1", "b": "AR 49 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 53 PA 5", "b": "AR 49 PA 5", "ratio": 1.0 }, { "a": "AR 53 PA 5 ALN 1", "b": "AR 49 PA 5 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 53 Involvement of notified bodies in conformity", "b": "Article 49 Involvement of notified bodies in conformity", "cut": false }, { "a": "electronic system referred to in Article 57, inform the other notified bodies of", "b": "electronic system referred to in Article 52, inform the other notified bodies of", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 56", "b": "AR 51", "ratio": 0.981, "identical": false, "numbering_only": false, "children": [ { "a": "AR 56 PA 1", "b": "AR 51 PA 1", "ratio": 1.0 }, { "a": "AR 56 PA 1 ALN 1", "b": "AR 51 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 56 PA 2", "b": "AR 51 PA 2", "ratio": 1.0 }, { "a": "AR 56 PA 2 ALN 1", "b": "AR 51 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 56 PA 3", "b": "AR 51 PA 3", "ratio": 0.912 }, { "a": "AR 56 PA 3 ALN 1", "b": "AR 51 PA 3 ALN 1", "ratio": 0.909 }, { "a": "AR 56 PA 4", "b": "AR 51 PA 4", "ratio": 1.0 }, { "a": "AR 56 PA 4 ALN 1", "b": "AR 51 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 56 PA 5", "b": "AR 51 PA 5", "ratio": 0.978 }, { "a": "AR 56 PA 5 ALN 1", "b": "AR 51 PA 5 ALN 1", "ratio": 0.978 }, { "a": "AR 56 PA 6", "b": "AR 51 PA 6", "ratio": 0.969 }, { "a": "AR 56 PA 6 ALN 1", "b": "AR 51 PA 6 ALN 1", "ratio": 0.968 } ], "passages": [ { "a": "Article 56 Certificates of conformity 1. The certificates", "b": "Article 51 Certificates of conformity 1. The certificates", "cut": false }, { "a": "to certain groups of patients or require manufacturers to undertake specific PMCF", "b": "to certain groups of patients or users or require manufacturers to undertake specific PMPF", "cut": false }, { "a": "or require manufacturers to undertake specific PMCF studies pursuant to Part B of", "b": "or require manufacturers to undertake specific PMPF studies pursuant to Part B of", "cut": false }, { "a": "pursuant to Part B of Annex XIV. 4. Where a notified body finds", "b": "pursuant to Part B of Annex XIII. 4. Where a notified body finds", "cut": false }, { "a": "electronic system referred to in Article 57 any information regarding certificates issued, including", "b": "electronic system referred to in Article 52 any information regarding certificates issued, including", "cut": false }, { "a": "delegated acts in accordance with Article 115 amending the minimum content of the", "b": "delegated acts in accordance with Article 108 amending the minimum content of the", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 58", "b": "AR 53", "ratio": 0.995, "identical": false, "numbering_only": true, "children": [ { "a": "AR 58 PA 1", "b": "AR 53 PA 1", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1", "b": "AR 53 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1 PTA (a)", "b": "AR 53 PA 1 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1 PTA (b)", "b": "AR 53 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1 PTA (c)", "b": "AR 53 PA 1 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1 PTA (d)", "b": "AR 53 PA 1 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 58 PA 1 ALN 1 PTA (e)", "b": "AR 53 PA 1 ALN 1 PTA (e)", "ratio": 1.0 }, { "a": "AR 58 PA 2", "b": "AR 53 PA 2", "ratio": 1.0 }, { "a": "AR 58 PA 2 ALN 1", "b": "AR 53 PA 2 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 58 Voluntary change of notified body 1.", "b": "Article 53 Voluntary change of notified body 1.", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 60", "b": "AR 55", "ratio": 0.972, "identical": false, "numbering_only": false, "children": [ { "a": "AR 60 PA 1", "b": "AR 55 PA 1", "ratio": 0.976 }, { "a": "AR 60 PA 1 ALN 1", "b": "AR 55 PA 1 ALN 1", "ratio": 0.976 }, { "a": "AR 60 PA 2", "b": "AR 55 PA 2", "ratio": 0.979 }, { "a": "AR 60 PA 2 ALN 1", "b": "AR 55 PA 2 ALN 1", "ratio": 0.979 } ], "passages": [ { "a": "Article 60 Certificate of free sale 1. For", "b": "Article 55 Certificate of free sale 1. For", "cut": false }, { "a": "the device in question bearing the CE marking in accordance with this Regulation may", "b": "the device in question bearing the CE-marking in accordance with this Regulation may", "cut": false }, { "a": "to the UDI database under Article 29. Where a notified body has issued", "b": "to the UDI database under Article 26. Where a notified body has issued", "cut": false }, { "a": "issued a certificate pursuant to Article 56, the certificate of free sale shall", "b": "issued a certificate pursuant to Article 51, the certificate of free sale shall", "cut": false }, { "a": "advisory procedure referred to in Article 114(2).", "b": "advisory procedure referred to in Article 107(2).", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 63", "b": "AR 59", "ratio": 0.949, "identical": false, "numbering_only": false, "children": [ { "a": "AR 63 PA 1", "b": "AR 59 PA 1", "ratio": 0.988 }, { "a": "AR 63 PA 1 ALN 1", "b": "AR 59 PA 1 ALN 1", "ratio": 0.988 }, { "a": "AR 63 PA 2", "b": "AR 59 PA 2", "ratio": 0.925 }, { "a": "AR 63 PA 2 ALN 1", "b": "AR 59 PA 2 ALN 1", "ratio": 0.925 }, { "a": "AR 63 PA 2 ALN 1 PTA (a)", "b": "AR 59 PA 2 ALN 1 PTA (a)", "ratio": 0.915 }, { "a": "AR 63 PA 2 ALN 1 PTA (a) PTI (ii)", "b": "AR 59 PA 2 ALN 1 PTA (a) PTI (ii)", "ratio": 0.956 }, { "a": "AR 63 PA 2 ALN 1 PTA (a) PTI (iv)", "b": "AR 59 PA 2 ALN 1 PTA (a) PTI (iv)", "ratio": 0.905 }, { "a": "AR 63 PA 2 ALN 1 PTA (b)", "b": "AR 59 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 63 PA 2 ALN 1 PTA (c)", "b": "AR 59 PA 2 ALN 1 PTA (c)", "ratio": 0.977 }, { "a": "AR 63 PA 3", "b": "AR 59 PA 3", "ratio": 1.0 }, { "a": "AR 63 PA 3 ALN 1", "b": "AR 59 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 63 PA 4", "b": "AR 59 PA 4", "ratio": 1.0 }, { "a": "AR 63 PA 4 ALN 1", "b": "AR 59 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 63 PA 5", "b": "AR 59 PA 5", "ratio": 1.0 }, { "a": "AR 63 PA 5 ALN 1", "b": "AR 59 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 63 PA 7", "b": "AR 59 PA 7", "ratio": 0.962 }, { "a": "AR 63 PA 7 ALN 1", "b": "AR 59 PA 7 ALN 1", "ratio": 0.961 } ], "passages": [ { "a": "Article 63 Informed consent 1. Informed consent shall", "b": "Article 59 Informed consent 1. Informed consent shall", "cut": false }, { "a": "her decision to participate in the clinical investigation. 2. Information given to the subject", "b": "her decision to participate in the performance study. 2. Information given to the subject", "cut": false }, { "a": "implications, risks and inconveniences of the clinical investigations; (ii) the subject's rights and guarantees", "b": "implications, risks and inconveniences of the performance study; (ii) the subject's rights and guarantees", "cut": false }, { "a": "the right to withdraw from the clinical investigation at any time without any resulting", "b": "the right to withdraw from the performance study at any time without any resulting", "cut": false }, { "a": "(iii) the conditions under which the clinical investigations is to be conducted, including the", "b": "(iii) the conditions under which the performance study is to be conducted, including the", "cut": false }, { "a": "of the subject's participation in the clinical investigation; and (iv) the possible treatment alternatives,", "b": "of the subject's participation in the performance study; and (iv) the possible treatment alternatives,", "cut": false }, { "a": "participation of the subject in the clinical investigation is discontinued; (b) be kept comprehensive,", "b": "participation of the subject in the performance study is discontinued; (b) be kept comprehensive,", "cut": false }, { "a": "is appropriately qualified under national law; (d) include information about the applicable", "b": "is appropriately qualified under national law; and (d) include information about the applicable", "cut": false }, { "a": "compensation system referred to in Article 69; and (e) include the Union-wide unique single", "b": "compensation system referred to in Article 65; (e) include the Union-wide unique single", "cut": false }, { "a": "the Union-wide unique single identification number of the clinical investigation referred to in", "b": "the Union-wide unique single identification number for the performance study referred to in", "cut": false }, { "a": "unique single identification number of the clinical investigation referred to in Article 70(1) and", "b": "unique single identification number for the performance study referred to in Article 66(1) and", "cut": false }, { "a": "clinical investigation referred to in Article 70(1) and information about the availability of", "b": "performance study referred to in Article 66(1) and information about the availability of", "cut": false } ], "passages_omitted": 8, "passages_withheld": false, "headings_equal": true }, { "a": "AR 67", "b": "AR 63", "ratio": 0.925, "identical": false, "numbering_only": false, "children": [ { "a": "AR 67 ALN 1", "b": "AR 63 ALN 1", "ratio": 0.943 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 68", "b": "AR 64", "ratio": 0.933, "identical": false, "numbering_only": false, "children": [ { "a": "AR 68 PA 1", "b": "AR 64 PA 1", "ratio": 0.925 }, { "a": "AR 68 PA 1 ALN 1", "b": "AR 64 PA 1 ALN 1", "ratio": 0.924 }, { "a": "AR 68 PA 1 ALN 1 PTA (a)", "b": "AR 64 PA 1 ALN 1 PTA (a)", "ratio": 0.946 }, { "a": "AR 68 PA 1 ALN 1 PTA (b)", "b": "AR 64 PA 1 ALN 1 PTA (b)", "ratio": 0.962 }, { "a": "AR 68 PA 1 ALN 1 PTA (c)", "b": "AR 64 PA 1 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 68 PA 1 ALN 1 PTA (d)", "b": "AR 64 PA 1 ALN 1 PTA (d)", "ratio": 0.92 }, { "a": "AR 68 PA 1 ALN 1 PTA (e)", "b": "AR 64 PA 1 ALN 1 PTA (e)", "ratio": 0.934 }, { "a": "AR 68 PA 1 ALN 1 PTA (f)", "b": "AR 64 PA 1 ALN 1 PTA (f)", "ratio": 0.926 }, { "a": "AR 68 PA 2", "b": "AR 64 PA 2", "ratio": 0.955 }, { "a": "AR 68 PA 2 ALN 1", "b": "AR 64 PA 2 ALN 1", "ratio": 0.955 }, { "a": "AR 68 PA 2 ALN 1 PTA (a)", "b": "AR 64 PA 2 ALN 1 PTA (a)", "ratio": 0.98 }, { "a": "AR 68 PA 2 ALN 1 PTA (b)", "b": "AR 64 PA 2 ALN 1 PTA (b)", "ratio": 0.983 }, { "a": "AR 68 PA 2 ALN 2", "b": "AR 64 PA 2 ALN 2", "ratio": 0.956 }, { "a": "AR 68 PA 3", "b": "AR 64 PA 3", "ratio": 0.947 }, { "a": "AR 68 PA 3 ALN 1", "b": "AR 64 PA 3 ALN 1", "ratio": 0.946 } ], "passages": [ { "a": "Article 68 Clinical investigations in emergency situations 1. By way", "b": "Article 64 Performance studies in emergency situations 1. 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performance study will have the potential to produce", "cut": false }, { "a": "any objections to participate in the clinical investigation previously expressed by the subject; (e)", "b": "any objections to participate in the performance study previously expressed by the subject; (e)", "cut": false } ], "passages_omitted": 10, "passages_withheld": false, "headings_equal": false }, { "a": "AR 69", "b": "AR 65", "ratio": 0.948, "identical": false, "numbering_only": false, "children": [ { "a": "AR 69 PA 1", "b": "AR 65 PA 1", "ratio": 0.967 }, { "a": "AR 69 PA 1 ALN 1", "b": "AR 65 PA 1 ALN 1", "ratio": 0.967 }, { "a": "AR 69 PA 2", "b": "AR 65 PA 2", "ratio": 0.938 }, { "a": "AR 69 PA 2 ALN 1", "b": "AR 65 PA 2 ALN 1", "ratio": 0.935 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 72", "b": "AR 68", "ratio": 0.926, "identical": false, "numbering_only": false, "children": [ { "a": "AR 72 PA 2", "b": "AR 68 PA 2", "ratio": 0.925 }, { "a": "AR 72 PA 2 ALN 1", "b": "AR 68 PA 2 ALN 1", "ratio": 0.925 }, { "a": "AR 72 PA 2 ALN 1 PTA (b)", "b": "AR 68 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 72 PA 3", "b": "AR 68 PA 3", "ratio": 0.964 }, { "a": "AR 72 PA 3 ALN 1", "b": "AR 68 PA 3 ALN 1", "ratio": 0.964 }, { "a": "AR 72 PA 4", "b": "AR 68 PA 4", "ratio": 1.0 }, { "a": "AR 72 PA 4 ALN 1", "b": "AR 68 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 72 PA 6", "b": "AR 68 PA 6", "ratio": 0.964 }, { "a": "AR 72 PA 6 ALN 1", "b": "AR 68 PA 6 ALN 1", "ratio": 0.963 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 73", "b": "AR 69", "ratio": 0.928, "identical": false, "numbering_only": false, "children": [ { "a": "AR 73 PA 2", "b": "AR 69 PA 2", "ratio": 0.922 }, { "a": "AR 73 PA 2 ALN 1", "b": "AR 69 PA 2 ALN 1", "ratio": 0.922 }, { "a": "AR 73 PA 3", "b": "AR 69 PA 3", "ratio": 0.983 }, { "a": "AR 73 PA 3 ALN 1", "b": "AR 69 PA 3 ALN 1", "ratio": 0.983 }, { "a": "AR 73 PA 3 ALN 1 PTA (a)", "b": "AR 69 PA 3 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 73 PA 3 ALN 1 PTA (b)", "b": "AR 69 PA 3 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 73 PA 4", "b": "AR 69 PA 4", "ratio": 1.0 }, { "a": "AR 73 PA 4 ALN 1", "b": "AR 69 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 73 PA 5", "b": "AR 69 PA 5", "ratio": 1.0 }, { "a": "AR 73 PA 5 ALN 1", "b": "AR 69 PA 5 ALN 1", "ratio": 1.0 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 75", "b": "AR 71", "ratio": 0.915, "identical": false, "numbering_only": false, "children": [ { "a": "AR 75 PA 1", "b": "AR 71 PA 1", "ratio": 0.922 }, { "a": "AR 75 PA 1 ALN 1", "b": "AR 71 PA 1 ALN 1", "ratio": 0.922 }, { "a": "AR 75 PA 3", "b": "AR 71 PA 3", "ratio": 0.919 }, { "a": "AR 75 PA 3 ALN 1", "b": "AR 71 PA 3 ALN 1", "ratio": 0.918 }, { "a": "AR 75 PA 3 ALN 1 PTA (b)", "b": "AR 71 PA 3 ALN 1 PTA (b)", "ratio": 0.944 }, { "a": "AR 75 PA 4", "b": "AR 71 PA 4", "ratio": 1.0 }, { "a": "AR 75 PA 4 ALN 1", "b": "AR 71 PA 4 ALN 1", "ratio": 1.0 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 76", "b": "AR 72", "ratio": 0.928, "identical": false, "numbering_only": false, "children": [ { "a": "AR 76 PA 2", "b": "AR 72 PA 2", "ratio": 1.0 }, { "a": "AR 76 PA 2 ALN 1", "b": "AR 72 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 76 PA 3", "b": "AR 72 PA 3", "ratio": 0.915 }, { "a": "AR 76 PA 3 ALN 1", "b": "AR 72 PA 3 ALN 1", "ratio": 0.914 }, { "a": "AR 76 PA 4", "b": "AR 72 PA 4", "ratio": 0.974 }, { "a": "AR 76 PA 4 ALN 1", "b": "AR 72 PA 4 ALN 1", "ratio": 0.974 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": false }, { "a": "AR 78", "b": "AR 74", "ratio": 0.935, "identical": false, "numbering_only": false, "children": [ { "a": "AR 78 PA 2", "b": "AR 74 PA 2", "ratio": 0.956 }, { "a": "AR 78 PA 2 ALN 1", "b": "AR 74 PA 2 ALN 1", "ratio": 0.955 }, { "a": "AR 78 PA 4", "b": "AR 74 PA 4", "ratio": 0.98 }, { "a": "AR 78 PA 4 ALN 1", "b": "AR 74 PA 4 ALN 1", "ratio": 0.982 }, { "a": "AR 78 PA 4 ALN 1 PTA (a)", "b": "AR 74 PA 4 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 78 PA 4 ALN 1 PTA (b)", "b": "AR 74 PA 4 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 78 PA 4 ALN 1 PTA (c)", "b": "AR 74 PA 4 ALN 1 PTA (c)", "ratio": 0.92 }, { "a": "AR 78 PA 4 ALN 1 PTA (d)", "b": "AR 74 PA 4 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 78 PA 4 ALN 2", "b": "AR 74 PA 4 ALN 2", "ratio": 0.96 }, { "a": "AR 78 PA 5", "b": "AR 74 PA 5", "ratio": 1.0 }, { "a": "AR 78 PA 5 ALN 1", "b": "AR 74 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 78 PA 6", "b": "AR 74 PA 6", "ratio": 0.925 }, { "a": "AR 78 PA 6 ALN 1", "b": "AR 74 PA 6 ALN 1", "ratio": 0.923 }, { "a": "AR 78 PA 8", "b": "AR 74 PA 8", "ratio": 0.962 }, { "a": "AR 78 PA 8 ALN 1", "b": "AR 74 PA 8 ALN 1", "ratio": 0.935 }, { "a": "AR 78 PA 8 ALN 2", "b": "AR 74 PA 8 ALN 2", "ratio": 0.976 }, { "a": "AR 78 PA 8 ALN 2 PTA (a)", "b": "AR 74 PA 8 ALN 2 PTA (a)", "ratio": 0.933 }, { "a": "AR 78 PA 8 ALN 2 PTA (b)", "b": "AR 74 PA 8 ALN 2 PTA (b)", "ratio": 1.0 }, { "a": "AR 78 PA 8 ALN 2 PTA (c)", "b": "AR 74 PA 8 ALN 2 PTA (c)", "ratio": 1.0 }, { "a": "AR 78 PA 8 ALN 3", "b": "AR 74 PA 8 ALN 3", "ratio": 0.962 }, { "a": "AR 78 PA 9", "b": "AR 74 PA 9", "ratio": 0.946 }, { "a": "AR 78 PA 9 ALN 1", "b": "AR 74 PA 9 ALN 1", "ratio": 0.944 }, { "a": "AR 78 PA 10", "b": "AR 74 PA 10", "ratio": 0.923 }, { "a": "AR 78 PA 10 ALN 1", "b": "AR 74 PA 10 ALN 1", "ratio": 0.922 }, { "a": "AR 78 PA 11", "b": "AR 74 PA 11", "ratio": 0.928 }, { "a": "AR 78 PA 11 ALN 1", "b": "AR 74 PA 11 ALN 1", "ratio": 0.928 }, { "a": "AR 78 PA 13", "b": "AR 74 PA 13", "ratio": 1.0 }, { "a": "AR 78 PA 13 ALN 1", "b": "AR 74 PA 13 ALN 1", "ratio": 1.0 }, { "a": "AR 78 PA 14", "b": "AR 74 PA 14", "ratio": 0.918 }, { "a": "AR 78 PA 14 ALN 2", "b": "AR 74 PA 14 ALN 2", "ratio": 0.967 } ], "passages": [ { "a": "Article 78 Coordinated assessment procedure for clinical investigations", "b": "Article 74 Coordinated assessment procedure for performance studies", "cut": false }, { "a": "Article 78 Coordinated assessment procedure for clinical investigations 1. By means of the electronic", "b": "Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic", "cut": false }, { "a": "electronic system referred to in Article 73, the sponsor of a clinical investigation", "b": "electronic system referred to in Article 69, the sponsor of a performance study", "cut": false }, { "a": "Article 73, the sponsor of a clinical investigation to be conducted in more than", "b": "Article 69, the sponsor of a performance study to be conducted in more than", "cut": false }, { "a": "submit, for the purpose of Article 70, a single application that, upon receipt,", "b": "submit, for the purpose of Article 66, a single application that, upon receipt,", "cut": false }, { "a": "all Member States in which the clinical investigation is to be conducted. 2. The", "b": "all Member States in which the performance study is to be conducted. 2. The", "cut": false }, { "a": "the Member States in which the clinical investigation is to be conducted acts as", "b": "the Member States in which the performance study is to be conducted acts as", "cut": false }, { "a": "The Member States in which the clinical investigation is to be conducted shall, within", "b": "The Member States in which the performance study is to be conducted shall, within", "cut": false }, { "a": "the documentation referred to in Chapter II of Annex XV. However, the completeness", "b": "the documentation referred to in Chapter I of Annex XIV. However, the completeness", "cut": false }, { "a": "to in Chapter II of Annex XV. However, the completeness of the documentation", "b": "to in Chapter I of Annex XIV. However, the completeness of the documentation", "cut": false }, { "a": "documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter", "b": "documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter", "cut": false }, { "a": "4.2, 4.3 and 4.4 of Chapter II of Annex XV shall be assessed", "b": "4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c)", "cut": false } ], "passages_omitted": 41, "passages_withheld": false, "headings_equal": false }, { "a": "AR 80", "b": "AR 76", "ratio": 0.923, "identical": false, "numbering_only": false, "children": [ { "a": "AR 80 PA 1", "b": "AR 76 PA 1", "ratio": 0.954 }, { "a": "AR 80 PA 1 ALN 1", "b": "AR 76 PA 1 ALN 1", "ratio": 0.953 }, { "a": "AR 80 PA 1 ALN 1 PTA (b)", "b": "AR 76 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 80 PA 1 ALN 1 PTA (c)", "b": "AR 76 PA 1 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 80 PA 1 ALN 1 PTA (d)", "b": "AR 76 PA 1 ALN 1 PTA (d)", "ratio": 1.0 }, { "a": "AR 80 PA 2", "b": "AR 76 PA 2", "ratio": 0.943 }, { "a": "AR 80 PA 2 ALN 1", "b": "AR 76 PA 2 ALN 1", "ratio": 0.93 }, { "a": "AR 80 PA 2 ALN 1 PTA (a)", "b": "AR 76 PA 2 ALN 1 PTA (a)", "ratio": 0.945 }, { "a": "AR 80 PA 2 ALN 1 PTA (b)", "b": "AR 76 PA 2 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 80 PA 2 ALN 1 PTA (c)", "b": "AR 76 PA 2 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 80 PA 2 ALN 2", "b": "AR 76 PA 2 ALN 2", "ratio": 1.0 }, { "a": "AR 80 PA 2 ALN 3", "b": "AR 76 PA 2 ALN 3", "ratio": 0.92 }, { "a": "AR 80 PA 4", "b": "AR 76 PA 4", "ratio": 0.939 }, { "a": "AR 80 PA 4 ALN 1", "b": "AR 76 PA 4 ALN 1", "ratio": 0.91 }, { "a": "AR 80 PA 4 ALN 3", "b": "AR 76 PA 4 ALN 3", "ratio": 1.0 }, { "a": "AR 80 PA 6", "b": "AR 76 PA 6", "ratio": 0.92 }, { "a": "AR 80 PA 6 ALN 1", "b": "AR 76 PA 6 ALN 1", "ratio": 0.917 } ], "passages": [ { "a": "Article 80 Recording and reporting of adverse events", "b": "Article 76 Recording and reporting of adverse events", "cut": false }, { "a": "of adverse events that occur during clinical investigations 1. The sponsor shall fully record", "b": "of adverse events that occur during performance studies 1. The sponsor shall fully record", "cut": false }, { "a": "of a type identified in the clinical investigation plan as being critical to the", "b": "of a type identified in the performance study plan as being critical to the", "cut": false }, { "a": "evaluation of the results of that clinical investigation; (b) any serious adverse event; (c)", "b": "evaluation of the results of that performance study; (b) any serious adverse event; (c)", "cut": false }, { "a": "to (c). 2. The sponsor shall report, without delay to all Member States", "b": "to (c). 2. The sponsor shall report without delay to all Member States", "cut": false }, { "a": "to all Member States in which the clinical investigation is being conducted, all of the", "b": "to all Member States in which a performance study is being conducted all of the", "cut": false }, { "a": "which the clinical investigation is being conducted, all of the following by means", "b": "which a performance study is being conducted all of the following by means", "cut": false }, { "a": "electronic system referred to in Article 73: (a) any serious adverse event that", "b": "electronic system referred to in Article 69: (a) any serious adverse event that", "cut": false }, { "a": "has a causal relationship with the investigational device, the comparator or the investigation", "b": "has a causal relationship with the device, the comparator or the study", "cut": false }, { "a": "investigational device, the comparator or the investigation procedure or where such causal relationship", "b": "the device, the comparator or the study procedure or where such causal relationship", "cut": false }, { "a": "any Member State in which the clinical investigation is being conducted, the sponsor shall", "b": "any Member State in which the performance study is being conducted, the sponsor shall", "cut": false }, { "a": "the Member States in which the clinical investigation is being conducted any event referred", "b": "the Member States in which the performance study is being conducted any event referred", "cut": false } ], "passages_omitted": 18, "passages_withheld": false, "headings_equal": false }, { "a": "AR 81", "b": "AR 77", "ratio": 0.92, "identical": false, "numbering_only": false, "children": [ { "a": "AR 81 ALN 1", "b": "AR 77 ALN 1", "ratio": 0.919 }, { "a": "AR 81 ALN 1 PTA (b)", "b": "AR 77 ALN 1 PTA (b)", "ratio": 0.917 }, { "a": "AR 81 ALN 1 PTA (d)", "b": "AR 77 ALN 1 PTA (d)", "ratio": 0.929 }, { "a": "AR 81 ALN 1 PTA (e)", "b": "AR 77 ALN 1 PTA (e)", "ratio": 0.95 }, { "a": "AR 81 ALN 1 PTA (f)", "b": "AR 77 ALN 1 PTA (f)", "ratio": 0.967 }, { "a": "AR 81 ALN 1 PTA (g)", "b": "AR 77 ALN 1 PTA (g)", "ratio": 0.926 }, { "a": "AR 81 ALN 2", "b": "AR 77 ALN 2", "ratio": 0.957 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 83", "b": "AR 78", "ratio": 0.975, "identical": false, "numbering_only": false, "children": [ { "a": "AR 83 PA 1", "b": "AR 78 PA 1", "ratio": 0.962 }, { "a": "AR 83 PA 1 ALN 1", "b": "AR 78 PA 1 ALN 1", "ratio": 0.961 }, { "a": "AR 83 PA 2", "b": "AR 78 PA 2", "ratio": 1.0 }, { "a": "AR 83 PA 2 ALN 1", "b": "AR 78 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 83 PA 3", "b": "AR 78 PA 3", "ratio": 0.973 }, { "a": "AR 83 PA 3 ALN 1", "b": "AR 78 PA 3 ALN 1", "ratio": 0.972 }, { "a": "AR 83 PA 3 ALN 1 PTA (a)", "b": "AR 78 PA 3 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 83 PA 3 ALN 1 PTA (b)", "b": "AR 78 PA 3 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 83 PA 3 ALN 1 PTA (e)", "b": "AR 78 PA 3 ALN 1 PTA (e)", "ratio": 1.0 }, { "a": "AR 83 PA 3 ALN 1 PTA (f)", "b": "AR 78 PA 3 ALN 1 PTA (f)", "ratio": 1.0 }, { "a": "AR 83 PA 3 ALN 1 PTA (g)", "b": "AR 78 PA 3 ALN 1 PTA (g)", "ratio": 1.0 }, { "a": "AR 83 PA 3 ALN 1 PTA (h)", "b": "AR 78 PA 3 ALN 1 PTA (h)", "ratio": 0.909 }, { "a": "AR 83 PA 3 ALN 2", "b": "AR 78 PA 3 ALN 2", "ratio": 1.0 }, { "a": "AR 83 PA 4", "b": "AR 78 PA 4", "ratio": 0.984 }, { "a": "AR 83 PA 4 ALN 1", "b": "AR 78 PA 4 ALN 1", "ratio": 0.984 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 85", "b": "AR 80", "ratio": 0.92, "identical": false, "numbering_only": false, "children": [ { "a": "AR 85 ALN 1", "b": "AR 80 ALN 1", "ratio": 0.929 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 87", "b": "AR 82", "ratio": 0.965, "identical": false, "numbering_only": false, "children": [ { "a": "AR 87 PA 1", "b": "AR 82 PA 1", "ratio": 0.935 }, { "a": "AR 87 PA 1 ALN 1", "b": "AR 82 PA 1 ALN 1", "ratio": 0.932 }, { "a": "AR 87 PA 1 ALN 1 PTA (a)", "b": "AR 82 PA 1 ALN 1 PTA (a)", "ratio": 0.9 }, { "a": "AR 87 PA 1 ALN 1 PTA (b)", "b": "AR 82 PA 1 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 87 PA 1 ALN 2", "b": "AR 82 PA 1 ALN 2", "ratio": 0.95 }, { "a": "AR 87 PA 2", "b": "AR 82 PA 2", "ratio": 1.0 }, { "a": "AR 87 PA 2 ALN 1", "b": "AR 82 PA 2 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 3", "b": "AR 82 PA 3", "ratio": 0.929 }, { "a": "AR 87 PA 3 ALN 1", "b": "AR 82 PA 3 ALN 1", "ratio": 0.928 }, { "a": "AR 87 PA 4", "b": "AR 82 PA 4", "ratio": 1.0 }, { "a": "AR 87 PA 4 ALN 1", "b": "AR 82 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 5", "b": "AR 82 PA 5", "ratio": 1.0 }, { "a": "AR 87 PA 5 ALN 1", "b": "AR 82 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 6", "b": "AR 82 PA 6", "ratio": 1.0 }, { "a": "AR 87 PA 6 ALN 1", "b": "AR 82 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 7", "b": "AR 82 PA 7", "ratio": 1.0 }, { "a": "AR 87 PA 7 ALN 1", "b": "AR 82 PA 7 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 8", "b": "AR 82 PA 8", "ratio": 0.979 }, { "a": "AR 87 PA 8 ALN 1", "b": "AR 82 PA 8 ALN 1", "ratio": 0.979 }, { "a": "AR 87 PA 9", "b": "AR 82 PA 9", "ratio": 0.96 }, { "a": "AR 87 PA 9 ALN 1", "b": "AR 82 PA 9 ALN 1", "ratio": 0.959 }, { "a": "AR 87 PA 10", "b": "AR 82 PA 10", "ratio": 1.0 }, { "a": "AR 87 PA 10 ALN 1", "b": "AR 82 PA 10 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 10 ALN 2", "b": "AR 82 PA 10 ALN 2", "ratio": 1.0 }, { "a": "AR 87 PA 11", "b": "AR 82 PA 11", "ratio": 0.959 }, { "a": "AR 87 PA 11 ALN 1", "b": "AR 82 PA 11 ALN 1", "ratio": 1.0 }, { "a": "AR 87 PA 11 ALN 2", "b": "AR 82 PA 11 ALN 2", "ratio": 0.983 }, { "a": "AR 87 PA 11 ALN 3", "b": "AR 82 PA 11 ALN 3", "ratio": 0.919 } ], "passages": [ { "a": "Article 87 Reporting of serious incidents and field", "b": "Article 82 Reporting of serious incidents and field", "cut": false }, { "a": "safety corrective actions 1. Manufacturers of devices made available on the Union market,", "b": "safety corrective actions 1. Manufacturers of devices, made available on the Union market,", "cut": false }, { "a": "on the Union market, other than investigational devices, shall report, to the relevant competent", "b": "on the Union market, other than devices for performance study, shall report, to the relevant competent", "cut": false }, { "a": "competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any", "b": "competent authorities, in accordance with Articles 87(5) and (7), the following: (a) any", "cut": false }, { "a": "on the Union market, except expected side-effects which are clearly documented in the", "b": "on the Union market, except expected erroneous results which are clearly documented and quantified", "cut": false }, { "a": "expected side-effects which are clearly documented in the product information and quantified", "b": "erroneous results which are clearly documented and quantified in the product information and in", "cut": false }, { "a": "documented in the product information and quantified in the technical documentation and are", "b": "quantified in the product information and in the technical documentation and are", "cut": false }, { "a": "to trend reporting pursuant to Article 88; (b) any field safety corrective action", "b": "to trend reporting pursuant to Article 83; (b) any field safety corrective action", "cut": false }, { "a": "electronic system referred to in Article 92. 2. As a general rule, the", "b": "electronic system referred to in Article 87. 2. As a general rule, the", "cut": false }, { "a": "as referred to in point (a) of paragraph 1 immediately after they have established the", "b": "as referred to in point (a) immediately after they have established a", "cut": false }, { "a": "1 immediately after they have established the causal relationship between that incident and", "b": "(a) immediately after they have established a causal relationship between that incident and", "cut": false }, { "a": "that such causal relationship is reasonably possible and not later than 15 days", "b": "that such causal relationship is reasonably possible, and not later than 15 days", "cut": false } ], "passages_omitted": 13, "passages_withheld": false, "headings_equal": true }, { "a": "AR 89", "b": "AR 84", "ratio": 0.903, "identical": false, "numbering_only": false, "children": [ { "a": "AR 89 PA 1", "b": "AR 84 PA 1", "ratio": 0.984 }, { "a": "AR 89 PA 1 ALN 1", "b": "AR 84 PA 1 ALN 1", "ratio": 0.966 }, { "a": "AR 89 PA 1 ALN 2", "b": "AR 84 PA 1 ALN 2", "ratio": 1.0 }, { "a": "AR 89 PA 2", "b": "AR 84 PA 2", "ratio": 0.987 }, { "a": "AR 89 PA 2 ALN 1", "b": "AR 84 PA 2 ALN 1", "ratio": 0.986 }, { "a": "AR 89 PA 3", "b": "AR 84 PA 3", "ratio": 0.99 }, { "a": "AR 89 PA 3 ALN 1", "b": "AR 84 PA 3 ALN 1", "ratio": 0.992 }, { "a": "AR 89 PA 3 ALN 2", "b": "AR 84 PA 3 ALN 2", "ratio": 0.971 }, { "a": "AR 89 PA 4", "b": "AR 84 PA 4", "ratio": 1.0 }, { "a": "AR 89 PA 4 ALN 1", "b": "AR 84 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 89 PA 5", "b": "AR 84 PA 5", "ratio": 0.978 }, { "a": "AR 89 PA 5 ALN 1", "b": "AR 84 PA 5 ALN 1", "ratio": 0.977 }, { "a": "AR 89 PA 7", "b": "AR 84 PA 7", "ratio": 0.937 }, { "a": "AR 89 PA 7 ALN 1", "b": "AR 84 PA 7 ALN 1", "ratio": 0.936 }, { "a": "AR 89 PA 8", "b": "AR 84 PA 8", "ratio": 0.984 }, { "a": "AR 89 PA 8 ALN 1", "b": "AR 84 PA 8 ALN 1", "ratio": 0.992 }, { "a": "AR 89 PA 8 ALN 2", "b": "AR 84 PA 8 ALN 2", "ratio": 0.979 }, { "a": "AR 89 PA 8 ALN 3", "b": "AR 84 PA 8 ALN 3", "ratio": 0.963 }, { "a": "AR 89 PA 9", "b": "AR 84 PA 9", "ratio": 0.995 }, { "a": "AR 89 PA 9 ALN 1", "b": "AR 84 PA 9 ALN 1", "ratio": 1.0 }, { "a": "AR 89 PA 9 ALN 1 PTA (a)", "b": "AR 84 PA 9 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 89 PA 9 ALN 1 PTA (b)", "b": "AR 84 PA 9 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 89 PA 9 ALN 2", "b": "AR 84 PA 9 ALN 2", "ratio": 1.0 }, { "a": "AR 89 PA 9 ALN 3", "b": "AR 84 PA 9 ALN 3", "ratio": 1.0 }, { "a": "AR 89 PA 9 ALN 4", "b": "AR 84 PA 9 ALN 4", "ratio": 0.97 }, { "a": "AR 89 PA 10", "b": "AR 84 PA 10", "ratio": 1.0 }, { "a": "AR 89 PA 10 ALN 1", "b": "AR 84 PA 10 ALN 1", "ratio": 1.0 }, { "a": "AR 89 PA 11", "b": "AR 84 PA 11", "ratio": 1.0 }, { "a": "AR 89 PA 11 ALN 1", "b": "AR 84 PA 11 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 89 Analysis of serious incidents and field", "b": "Article 84 Analysis of serious incidents and field", "cut": false }, { "a": "a serious incident pursuant to Article 87(1), the manufacturer shall, without delay, perform", "b": "a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform", "cut": false }, { "a": "the devices concerned. This shall include a risk assessment of the incident and", "b": "the devices concerned. This shall include risk assessment of the incident and", "cut": false }, { "a": "safety corrective action taking into account criteria as referred to in paragraph", "b": "safety corrective action taking into account the criteria as referred to in paragraph", "cut": false }, { "a": "their knowledge in accordance with Article 87 is evaluated centrally at national level", "b": "their knowledge in accordance with Article 82 is evaluated centrally at national level", "cut": false }, { "a": "reported serious incident and evaluate any related field safety corrective actions, taking into", "b": "reported serious incident and evaluate any field safety corrective actions, taking into", "cut": false }, { "a": "device, intended and potential users, and population affected. The competent authority shall", "b": "device, intended and potential users, and the population affected. The competent authority shall", "cut": false }, { "a": "national competent authority, manufacturers shall provide all documents necessary for the risk", "b": "national competent authority, manufacturers shall provide for all documents necessary for the risk", "cut": false }, { "a": "electronic system referred to in Article 92. The report shall set out conclusions", "b": "electronic system referred to in Article 87. The report shall set out conclusions", "cut": false }, { "a": "taken. 6. In the case of devices referred to in the first subparagraph of Article 1(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the", "b": "taken. 6. In the case of companion diagnostic, the evaluating competent authority or the", "cut": false }, { "a": "paragraph 9 of this Article shall, inform the national competent authority or the", "b": "paragraph 9 of this Article shall, depending on whether the relevant competent authority of the", "cut": false }, { "a": "of this Article shall, inform the national competent authority or the EMA, depending", "b": "Article shall, depending on whether the relevant competent authority of the Member State", "cut": false } ], "passages_omitted": 11, "passages_withheld": false, "headings_equal": true }, { "a": "AR 90", "b": "AR 85", "ratio": 0.981, "identical": false, "numbering_only": true, "children": [ { "a": "AR 90 ALN 1", "b": "AR 85 ALN 1", "ratio": 0.98 }, { "a": "AR 90 ALN 2", "b": "AR 85 ALN 2", "ratio": 1.0 } ], "passages": [ { "a": "Article 90 Analysis of vigilance data The Commission", "b": "Article 85 Analysis of vigilance data The Commission", "cut": false }, { "a": "electronic system referred to in Article 92, in order to identify trends, patterns", "b": "electronic system referred to in Article 87, in order to identify trends, patterns", "cut": false } ], "passages_omitted": 0, "passages_withheld": false, "headings_equal": true }, { "a": "AR 91", "b": "AR 86", "ratio": 0.951, "identical": false, "numbering_only": true, "children": [ { "a": "AR 91 ALN 1", "b": "AR 86 ALN 1", "ratio": 0.954 }, { "a": "AR 91 ALN 1 PTA (a)", "b": "AR 86 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 91 ALN 1 PTA (c)", "b": "AR 86 ALN 1 PTA (c)", "ratio": 1.0 }, { "a": "AR 91 ALN 1 PTA (d)", "b": "AR 86 ALN 1 PTA (d)", "ratio": 0.975 }, { "a": "AR 91 ALN 1 PTA (e)", "b": "AR 86 ALN 1 PTA (e)", "ratio": 0.941 }, { "a": "AR 91 ALN 1 PTA (f)", "b": "AR 86 ALN 1 PTA (f)", "ratio": 1.0 }, { "a": "AR 91 ALN 2", "b": "AR 86 ALN 2", "ratio": 0.957 } ], "passages": [], "passages_omitted": 0, "passages_withheld": true, "headings_equal": true }, { "a": "AR 92", "b": "AR 87", "ratio": 0.968, "identical": false, "numbering_only": false, "children": [ { "a": "AR 92 PA 1", "b": "AR 87 PA 1", "ratio": 0.941 }, { "a": "AR 92 PA 1 ALN 1", "b": "AR 87 PA 1 ALN 1", "ratio": 0.934 }, { "a": "AR 92 PA 1 ALN 1 PTA (b)", "b": "AR 87 PA 1 ALN 1 PTA (b)", "ratio": 0.917 }, { "a": "AR 92 PA 1 ALN 1 PTA (c)", "b": "AR 87 PA 1 ALN 1 PTA (c)", "ratio": 0.917 }, { "a": "AR 92 PA 1 ALN 1 PTA (e)", "b": "AR 87 PA 1 ALN 1 PTA (e)", "ratio": 0.917 }, { "a": "AR 92 PA 1 ALN 1 PTA (f)", "b": "AR 87 PA 1 ALN 1 PTA (f)", "ratio": 0.963 }, { "a": "AR 92 PA 1 ALN 2", "b": "AR 87 PA 1 ALN 2", "ratio": 1.0 }, { "a": "AR 92 PA 2", "b": "AR 87 PA 2", "ratio": 0.983 }, { "a": "AR 92 PA 2 ALN 1", "b": "AR 87 PA 2 ALN 1", "ratio": 0.983 }, { "a": "AR 92 PA 3", "b": "AR 87 PA 3", "ratio": 1.0 }, { "a": "AR 92 PA 3 ALN 1", "b": "AR 87 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 92 PA 4", "b": "AR 87 PA 4", "ratio": 1.0 }, { "a": "AR 92 PA 4 ALN 1", "b": "AR 87 PA 4 ALN 1", "ratio": 1.0 }, { "a": "AR 92 PA 5", "b": "AR 87 PA 5", "ratio": 0.978 }, { "a": "AR 92 PA 5 ALN 1", "b": "AR 87 PA 5 ALN 1", "ratio": 0.977 }, { "a": "AR 92 PA 6", "b": "AR 87 PA 6", "ratio": 0.95 }, { "a": "AR 92 PA 6 ALN 1", "b": "AR 87 PA 6 ALN 1", "ratio": 0.949 }, { "a": "AR 92 PA 7", "b": "AR 87 PA 7", "ratio": 0.973 }, { "a": "AR 92 PA 7 ALN 1", "b": "AR 87 PA 7 ALN 1", "ratio": 0.973 }, { "a": "AR 92 PA 7 ALN 1 PTA (a)", "b": "AR 87 PA 7 ALN 1 PTA (a)", "ratio": 0.944 }, { "a": "AR 92 PA 7 ALN 1 PTA (b)", "b": "AR 87 PA 7 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 92 PA 8", "b": "AR 87 PA 8", "ratio": 0.973 }, { "a": "AR 92 PA 8 ALN 1", "b": "AR 87 PA 8 ALN 1", "ratio": 0.972 }, { "a": "AR 92 PA 8 ALN 1 PTA (a)", "b": "AR 87 PA 8 ALN 1 PTA (a)", "ratio": 0.962 }, { "a": "AR 92 PA 8 ALN 1 PTA (b)", "b": "AR 87 PA 8 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 92 PA 9", "b": "AR 87 PA 9", "ratio": 0.98 }, { "a": "AR 92 PA 9 ALN 1", "b": "AR 87 PA 9 ALN 1", "ratio": 0.979 } ], "passages": [ { "a": "Article 92 Electronic system on vigilance and on", "b": "Article 87 Electronic system on vigilance and post-market", "cut": false }, { "a": "92 Electronic system on vigilance and on post-market surveillance 1. The Commission shall,", "b": "87 Electronic system on vigilance and post-market surveillance 1. The Commission shall,", "cut": false }, { "a": "and process the following information: (a) the reports by manufacturers on serious incidents", "b": "and process the following information: (a) reports by manufacturers on serious incidents", "cut": false }, { "a": "corrective actions referred to in Article 87(1) and Article 89(5); (b) the periodic", "b": "corrective actions referred to in Article 82(1) and Article 84(5); (b) the periodic", "cut": false }, { "a": "to in Article 87(1) and Article 89(5); (b) the periodic summary reports by", "b": "to in Article 82(1) and Article 84(5); (b) the periodic summary reports by", "cut": false }, { "a": "by manufacturers referred to in Article 87(9); (c) the reports by manufacturers on", "b": "by manufacturers referred to in Article 82(9); (c) the reports by manufacturers on", "cut": false }, { "a": "on trends referred to in Article 88; (d) the PSURs referred to in", "b": "on trends referred to in Article 83; (d) the PSURs referred to in", "cut": false }, { "a": "the PSURs referred to in Article 86; (e) the field safety notices by", "b": "the PSURs referred to in Article 81; (e) the field safety notices by", "cut": false }, { "a": "by manufacturers referred to in Article 89(8); (f) the information to be exchanged", "b": "by manufacturers referred to in Article 84(8); (f) the information to be exchanged", "cut": false }, { "a": "the Commission in accordance with Article 89(7) and (9). That electronic system shall", "b": "the Commission in accordance with Article 84(7) and (9). That electronic system shall", "cut": false }, { "a": "a certificate in accordance with Article 53. 3. The Commission shall ensure that", "b": "a certificate in accordance with Article 49. 3. The Commission shall ensure that", "cut": false }, { "a": "to in point (a) of Article 87(1) shall be automatically transmitted, upon receipt,", "b": "to in point (a) of Article 82(1), shall be automatically transmitted, upon receipt,", "cut": false } ], "passages_omitted": 7, "passages_withheld": false, "headings_equal": false }, { "a": "AR 93", "b": "AR 88", "ratio": 0.992, "identical": false, "numbering_only": true, "children": [ { "a": "AR 93 PA 1", "b": "AR 88 PA 1", "ratio": 1.0 }, { "a": "AR 93 PA 1 ALN 1", "b": "AR 88 PA 1 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 2", "b": "AR 88 PA 2", "ratio": 0.979 }, { "a": "AR 93 PA 2 ALN 1", "b": "AR 88 PA 2 ALN 1", "ratio": 0.979 }, { "a": "AR 93 PA 3", "b": "AR 88 PA 3", "ratio": 1.0 }, { "a": "AR 93 PA 3 ALN 1", "b": "AR 88 PA 3 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 3 ALN 1 PTA (a)", "b": "AR 88 PA 3 ALN 1 PTA (a)", "ratio": 1.0 }, { "a": "AR 93 PA 3 ALN 1 PTA (b)", "b": "AR 88 PA 3 ALN 1 PTA (b)", "ratio": 1.0 }, { "a": "AR 93 PA 4", "b": "AR 88 PA 4", "ratio": 0.971 }, { "a": "AR 93 PA 4 ALN 1", "b": "AR 88 PA 4 ALN 1", "ratio": 0.971 }, { "a": "AR 93 PA 5", "b": "AR 88 PA 5", "ratio": 1.0 }, { "a": "AR 93 PA 5 ALN 1", "b": "AR 88 PA 5 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 6", "b": "AR 88 PA 6", "ratio": 1.0 }, { "a": "AR 93 PA 6 ALN 1", "b": "AR 88 PA 6 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 7", "b": "AR 88 PA 7", "ratio": 0.986 }, { "a": "AR 93 PA 7 ALN 1", "b": "AR 88 PA 7 ALN 1", "ratio": 0.986 }, { "a": "AR 93 PA 8", "b": "AR 88 PA 8", "ratio": 0.985 }, { "a": "AR 93 PA 8 ALN 1", "b": "AR 88 PA 8 ALN 1", "ratio": 0.985 }, { "a": "AR 93 PA 9", "b": "AR 88 PA 9", "ratio": 1.0 }, { "a": "AR 93 PA 9 ALN 1", "b": "AR 88 PA 9 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 9 ALN 2", "b": "AR 88 PA 9 ALN 2", "ratio": 1.0 }, { "a": "AR 93 PA 10", "b": "AR 88 PA 10", "ratio": 1.0 }, { "a": "AR 93 PA 10 ALN 1", "b": "AR 88 PA 10 ALN 1", "ratio": 1.0 }, { "a": "AR 93 PA 11", "b": "AR 88 PA 11", "ratio": 1.0 }, { "a": "AR 93 PA 11 ALN 1", "b": "AR 88 PA 11 ALN 1", "ratio": 1.0 } ], "passages": [ { "a": "Article 93 Market surveillance activities 1. The competent", "b": "Article 88 Market surveillance activities 1. The competent", "cut": false }, { "a": "by the MDCG pursuant to Article 105 and local circumstances. 3. In order", "b": "by the MDCG pursuant to Article 99 and local circumstances. 3. In order", "cut": false }, { "a": "electronic system referred to in Article 100. 5. The competent authorities may confiscate,", "b": "electronic system referred to in Article 95. 5. The competent authorities may confiscate,", "cut": false }, { "a": "electronic system provided for in Article 100. 8. The Member States shall review", "b": "electronic system provided for in Article 95. 8. The Member States shall review", "cut": false }, { "a": "electronic system referred to in Article 100. 9. The competent authorities of the", "b": "electronic system referred to in Article 95. 9. 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