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Textual twins

Medical Devices Regulation Art. 68 and IVDR Art. 64 where the texts differ

textually similar (0.933) · 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. 68 and IVDR Art. 64 are textually similar: their words match at a ratio of 0.933, 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. 68IVDR Art. 64
1

Article 68 Clinical investigations in emergency situations 1. By way

Article 64 Performance studies in emergency situations 1. By way

2

derogation from point (f) of Article 62(4), from points (a) and (b) of

derogation from point (f) of Article 58(5), from points (a) and (b) of

3

points (a) and (b) of Article 64(1) and from points (a) and (b)

points (a) and (b) of Article 60(1) and from points (a) and (b)

4

points (a) and (b) of Article 65, informed consent to participate in a

points (a) and (b) of Article 61(1), informed consent to participate in a

5

informed consent to participate in a clinical investigation may be obtained, and information on

informed consent to participate in a performance study may be obtained, and information on

6

be obtained, and information on the clinical investigation may be given, after the decision

be obtained, and information on the performance studies may be given, after the decision

7

to include the subject in the clinical investigation, provided that that decision is taken

to include the subject in the performance study, provided that that decision is taken

8

subject, in accordance with the clinical investigation plan for that clinical investigation and

subject, in accordance with the clinical performance study plan for that performance study and

9

the clinical investigation plan for that clinical investigation and that all of the following

clinical performance study plan for that performance study and that all of the following

10

to receive prior information on the clinical investigation; (b) there are scientific grounds to

to receive prior information on the performance study; (b) there are scientific grounds to

11

participation of the subject in the clinical investigation will have the potential to produce

participation of the subject in the performance study will have the potential to produce

12

any objections to participate in the clinical investigation previously expressed by the subject; (e)

any objections to participate in the performance study previously expressed by the subject; (e)

10 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.