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Textual twins

Medical Devices Regulation Art. 56 and IVDR Art. 51 where the texts differ

textually similar (0.981) · 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. 56 and IVDR Art. 51 are textually similar: their words match at a ratio of 0.981, 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. 56IVDR Art. 51
1

Article 56 Certificates of conformity 1. The certificates

Article 51 Certificates of conformity 1. The certificates

2

to certain groups of patients or require manufacturers to undertake specific PMCF

to certain groups of patients or users or require manufacturers to undertake specific PMPF

3

or require manufacturers to undertake specific PMCF studies pursuant to Part B of

or require manufacturers to undertake specific PMPF studies pursuant to Part B of

4

pursuant to Part B of Annex XIV. 4. Where a notified body finds

pursuant to Part B of Annex XIII. 4. Where a notified body finds

5

electronic system referred to in Article 57 any information regarding certificates issued, including

electronic system referred to in Article 52 any information regarding certificates issued, including

6

delegated acts in accordance with Article 115 amending the minimum content of the

delegated acts in accordance with Article 108 amending the minimum content of the

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.