Textual twins
Medical Devices Regulation Art. 10 and IVDR Art. 10 where the texts differ
textually similar (0.931) · paired on the Medical Devices Regulation text of 19 July 2026 and the IVDR text of 10 January 2025 · headings the same
Medical Devices Regulation Art. 10 and IVDR Art. 10 are textually similar: their words match at a ratio of 0.931, where 1 is identical text. That says nothing about what either provision requires, or whether one should change because the other did.
Medical Devices Regulation Art. 10 on EUR-Lex (external, EUR-Lex) · IVDR Art. 10 on EUR-Lex (external, EUR-Lex) · Medical Devices Regulation Art. 10: its history · IVDR Art. 10: its history
Where the texts differ
Each passage is a differing span with up to 6 unchanged words either side, from the text as compared, spacing collapsed, and cut at 400 characters where it ends […]. It is an excerpt for reading where the two differ, not the verbatim text.
| Passage | Medical Devices Regulation Art. 10 | IVDR Art. 10 |
|---|---|---|
| 1 | I. 3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements | I. 3. Manufacturers shall conduct a performance evaluation in accordance with the requirements |
| 2 | the requirements set out in Article 61 and Annex XIV, including a PMCF. | the requirements set out in Article 56 and Annex XIII, including a PMPF. |
| 3 | out in Article 61 and Annex XIV, including a PMCF. 4. Manufacturers of | out in Article 56 and Annex XIII, including a PMPF. 4. Manufacturers shall |
| 4 | 61 and Annex XIV, including a PMCF. 4. Manufacturers of devices other than | 56 and Annex XIII, including a PMPF. 4. Manufacturers shall draw up and |
| 5 | XIV, including a PMCF. 4. Manufacturers of devices other than custom-made devices shall draw up and keep up | XIII, including a PMPF. 4. Manufacturers shall draw up and keep up |
| 6 | up and keep up to date technical documentation for those devices. The | up and keep up to date the technical documentation for those devices. The |
| 7 | delegated acts in accordance with Article 115 amending, in the light of technical | delegated acts in accordance with Article 108 amending, in the light of technical |
| 8 | 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 | the Annexes II and III. 5. Where compliance with the applicable requirements |
| 9 | procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration | procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration |
| 10 | of conformity in accordance with Article 19, and affix the CE marking of | of conformity in accordance with Article 17, and affix the CE marking of |
| 11 | of conformity in accordance with Article 20. 7. Manufacturers shall comply with the obligations | of conformity in accordance with Article 18. 6. Manufacturers shall comply with the obligations |
| 12 | UDI system referred to in Article 27 and with the registration obligations referred | UDI system referred to in Article 24 and with the registration obligations referred |
28 more passages not shown; read both on EUR-Lex.
Aligned sub-provisions
Medical Devices Regulation first, then IVDR, each with its word ratio.
- Art. 10(1) and Art. 10(1) · 1.000
- Art. 10(1)(1) and Art. 10(1)(1) · 1.000
- Art. 10(2) and Art. 10(2) · 1.000
- Art. 10(2)(1) and Art. 10(2)(1) · 1.000
- Art. 10(4) and Art. 10(4) · 0.944
- Art. 10(4)(1) and Art. 10(4)(1) · 0.936
- Art. 10(4)(2) and Art. 10(4)(2) · 0.960
- Art. 10(9) and Art. 10(8) · 0.960
- Art. 10(9)(1) and Art. 10(8)(1) · 0.953
- Art. 10(9)(2) and Art. 10(8)(2) · 1.000
- Art. 10(9)(3) and Art. 10(8)(3) · 0.959
- Art. 10(9)(3)(a) and Art. 10(8)(3)(a) · 1.000
- Art. 10(9)(3)(b) and Art. 10(8)(3)(b) · 1.000
- Art. 10(9)(3)(c) and Art. 10(8)(3)(c) · 1.000
- Art. 10(9)(3)(d) and Art. 10(8)(3)(d) · 1.000
- Art. 10(9)(3)(e) and Art. 10(8)(3)(e) · 0.960
- Art. 10(9)(3)(g) and Art. 10(8)(3)(g) · 1.000
- Art. 10(9)(3)(h) and Art. 10(8)(3)(h) · 0.931
- Art. 10(9)(3)(i) and Art. 10(8)(3)(i) · 0.933
- Art. 10(9)(3)(j) and Art. 10(8)(3)(j) · 1.000
- Art. 10(9)(3)(k) and Art. 10(8)(3)(k) · 1.000
- Art. 10(9)(3)(l) and Art. 10(8)(3)(l) · 1.000
- Art. 10(9)(3)(m) and Art. 10(8)(3)(m) · 1.000
- Art. 10(10) and Art. 10(9) · 0.900
- Art. 10(10)(1) and Art. 10(9)(1) · 0.947
- Art. 10(12) and Art. 10(11) · 0.976
- Art. 10(12)(1) and Art. 10(11)(1) · 0.986
- Art. 10(12)(2) and Art. 10(11)(2) · 0.981
- Art. 10(14) and Art. 10(13) · 0.997
- Art. 10(14)(1) and Art. 10(13)(1) · 1.000
- Art. 10(14)(2) and Art. 10(13)(2) · 1.000
- Art. 10(14)(3) and Art. 10(13)(3) · 1.000
- Art. 10(14)(4) and Art. 10(13)(4) · 1.000
- Art. 10(15) and Art. 10(14) · 0.946
- Art. 10(15)(1) and Art. 10(14)(1) · 0.972
- Art. 10(16) and Art. 10(15) · 0.986
- Art. 10(16)(1) and Art. 10(15)(1) · 1.000
- Art. 10(16)(2) and Art. 10(15)(2) · 1.000
Changes since the texts were paired
The record holds no change to either provision after the versions they were paired on.