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Textual twins

Medical Devices Regulation Art. 44 and IVDR Art. 40 where the texts differ

textually similar (0.988) · 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. 44 and IVDR Art. 40 are textually similar: their words match at a ratio of 0.988, 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. 44IVDR Art. 40
1

Article 44 Monitoring and re-assessment of notified bodies

Article 40 Monitoring and re-assessment of notified bodies

2

subsidiaries and subcontractors, as that personnel is in the process of conducting quality

subsidiaries and subcontractors, as that personnel in the process of conducting quality

3

manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in

manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in

4

documentation as further outlined in Article 45. 9. The authority responsible for notified

documentation as further outlined in Article 41. 9. The authority responsible for notified

5

with the procedure described in Article 39. The authority responsible for notified bodies

with the procedure described in Article 35. The authority responsible for notified bodies

6

dates referred to in the first subparagraph, upon request by the notified body

dates referred to in the first subparagraph upon request by the notified body

7

the results of the annual assessments conducted in accordance with paragraph 4 of

the results of the annual assessments performed in accordance with paragraph 4 of

8

suspend or terminate the ongoing complete re-assessment, taking into account its own resources

suspend or terminate the ongoing complete re-assessment taking into account its own resources

9

delegated acts in accordance with Article 115 in order to amend paragraph 10

delegated acts in accordance with Article 108 in order to amend paragraph 10

10

in order to amend paragraph 10 to modify the frequency at which

in order to amend paragraph 10 of this Article to modify the frequency at which

11

by the MDCG and the Commission; however it shall contain a summary which

by the MDCG and the Commission; however, it shall contain a summary which

12

electronic system referred to in Article 57.

electronic system referred to in Article 52.

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.