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Textual twins

Medical Devices Regulation Art. 39 and IVDR Art. 35 where the texts differ

textually similar (0.984) · 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. 39 and IVDR Art. 35 are textually similar: their words match at a ratio of 0.984, where 1 is identical text. That says nothing about what either provision requires, or whether one should change because the other did.

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.

PassageMedical Devices Regulation Art. 39IVDR Art. 35
1

Article 39 Assessment of the application 1. The

Article 35 Assessment of the application 1. The

2

the application referred to in Article 38 is complete and shall request the

the application referred to in Article 34 is complete and shall request the

3

Once the application is complete that authority shall send it to the

Once the application is complete that national authority shall send it to the

4

the list referred to in Article 40(2). One of the experts shall be

the list referred to in Article 36. One of the experts shall be

5

assessment team shall be comprised of experts who are competent to assess

assessment team shall be comprised of competent experts who are competent to assess

6

is initiated in accordance with Article 47(3), to ensure that the specific concern

is initiated in accordance with Article 43(3) to ensure that the specific concern

7

the application in accordance with Article 38. The joint assessment team may provide

the application in accordance with Article 34. The joint assessment team may provide

8

resulting from the assessment and summarise the assessment by the joint assessment

resulting from the assessment and summarise of the assessment by the joint assessment

9

The authority responsible for notified bodies shall following receipt of a corrective and

The authority responsible for notified bodies shall, following receipt of a corrective and

10

preventive action plan from the applicant body assess whether non-compliances identified during the

preventive action plan from the applicant body, assess whether non-compliances identified during the

11

The authority responsible for notified bodies shall having confirmed the corrective and preventive

The authority responsible for notified bodies shall, having confirmed the corrective and preventive

12

confirmed the corrective and preventive action plan forward it and its opinion thereon

confirmed the corrective and preventive action plan, forward it and its opinion thereon

3 more passages not shown; read both on EUR-Lex.

Aligned sub-provisions

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

Changes since the texts were paired

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