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Textual twins

Medical Devices Regulation Art. 42 and IVDR Art. 38 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. 42 and IVDR Art. 38 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. 42IVDR Art. 38
1

Article 42 Designation and notification procedure 1. Member

Article 38 Designation and notification procedure 1. Member

2

which the assessment pursuant to Article 39 was completed and which comply with

which the assessment pursuant to Article 35 was completed and which comply with

3

assessment activities as defined in this Regulation and the types of devices which

assessment activities as defined in this Regulation, and the types of devices which

4

assess and, without prejudice to Article 44, any conditions associated with the designation.

assess and, without prejudice to Article 40, any conditions associated with the designation.

5

assessment team referred to in Article 39(9) and the recommendation of the MDCG.

assessment team referred to in Article 35(9) and the recommendation of the MDCG.

6

State shall, without prejudice to Article 44, inform the Commission and the other

State shall, without prejudice to Article 40, inform the Commission and the other

7

notification in NANDO, the Commission shall also add to the electronic system referred

notification in NANDO, the Commission shall add to the electronic system referred

8

electronic system referred to in Article 57 the information relating to the notification

electronic system referred to in Article 52 the information relating to the notification

9

this Article and the opinion and responses referred to in paragraphs 7 and

this Article and the opinion and response referred to in paragraphs 7 and

10

valid in accordance with paragraph 11. 13. The Commission shall by 26 November

valid in accordance with paragraph 11. 13 The Commission shall by 26 November

11

examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG,

examination procedure referred to in Article 107(3). The Commission, after consulting the MDCG,

12

may update this list based, inter alia , on information arising from the coordination

may update this list based, inter alia, on information arising from the coordination

1 more passage 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.