Medical Devices Regulation Art. 47 and IVDR Art. 43: where the texts differ

textually similar (0.976) · 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. 47 and IVDR Art. 43 are textually similar: their words match at a ratio of 0.976, 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. 47 on EUR-Lex (external, EUR-Lex) · IVDR Art. 43 on EUR-Lex (external, EUR-Lex)

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. 47	IVDR Art. 43
1	Article 47 Challenge to the competence of notified	Article 43 Challenge to the competence of notified
2	the assessment procedure described in Article 39(3) and (4), where there is reasonable	the assessment procedure described in Article 35(3) and (5) where there is reasonable
3	procedure described in Article 39(3) and (4), where there is reasonable concern about	procedure described in Article 35(3) and (5) where there is reasonable concern about
4	shall follow the principles of Article 39. Alternatively, depending on the severity of	shall follow the principles of Article 35. Alternatively, depending on the severity of
5	the list established pursuant to Article 40 in an on-site assessment as part	the list established pursuant to Article 36 in an on-site assessment as part
6	assessment activities in accordance with Article 44 and as outlined in the annual	assessment activities in accordance with Article 40 and as outlined in the annual
7	annual assessment plan described in Article 44(4). 4. Where the Commission ascertains that	annual assessment plan described in Article 40(4) therein. 4. Where the Commission ascertains that
8	examination procedure referred to in Article 114(3). It shall notify the Member State	examination procedure referred to in Article 107(3). It shall notify the Member State
9	electronic system referred to in Article 57. 5. The Commission shall ensure that	electronic system referred to in Article 52. 5. The Commission shall ensure that

Aligned sub-provisions

Medical Devices Regulation first, then IVDR, each with its word ratio.

Art. 47(1) and Art. 43(1) · 1.000
Art. 47(1)(1) and Art. 43(1)(1) · 1.000
Art. 47(2) and Art. 43(2) · 1.000
Art. 47(2)(1) and Art. 43(2)(1) · 1.000
Art. 47(3) and Art. 43(3) · 0.961
Art. 47(3)(1) and Art. 43(3)(1) · 0.960
Art. 47(4) and Art. 43(4) · 0.982
Art. 47(4)(1) and Art. 43(4)(1) · 1.000
Art. 47(4)(2) and Art. 43(4)(2) · 0.969
Art. 47(5) and Art. 43(5) · 1.000
Art. 47(5)(1) and Art. 43(5)(1) · 1.000

Changes since the texts were paired

The record holds no change to either provision after the versions they were paired on.