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Textual twins

Medical Devices Regulation Art. 78 and IVDR Art. 74 where the texts differ

textually similar (0.935) · paired on the Medical Devices Regulation text of 19 July 2026 and the IVDR text of 10 January 2025 · headings different

Medical Devices Regulation Art. 78 and IVDR Art. 74 are textually similar: their words match at a ratio of 0.935, 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. 78IVDR Art. 74
1

Article 78 Coordinated assessment procedure for clinical investigations

Article 74 Coordinated assessment procedure for performance studies

2

Article 78 Coordinated assessment procedure for clinical investigations 1. By means of the electronic

Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic

3

electronic system referred to in Article 73, the sponsor of a clinical investigation

electronic system referred to in Article 69, the sponsor of a performance study

4

Article 73, the sponsor of a clinical investigation to be conducted in more than

Article 69, the sponsor of a performance study to be conducted in more than

5

submit, for the purpose of Article 70, a single application that, upon receipt,

submit, for the purpose of Article 66, a single application that, upon receipt,

6

all Member States in which the clinical investigation is to be conducted. 2. The

all Member States in which the performance study is to be conducted. 2. The

7

the Member States in which the clinical investigation is to be conducted acts as

the Member States in which the performance study is to be conducted acts as

8

The Member States in which the clinical investigation is to be conducted shall, within

The Member States in which the performance study is to be conducted shall, within

9

the documentation referred to in Chapter II of Annex XV. However, the completeness

the documentation referred to in Chapter I of Annex XIV. However, the completeness

10

to in Chapter II of Annex XV. However, the completeness of the documentation

to in Chapter I of Annex XIV. However, the completeness of the documentation

11

documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter

documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter

12

4.2, 4.3 and 4.4 of Chapter II of Annex XV shall be assessed

4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c)

41 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.