Medical Devices Regulation Art. 63 and IVDR Art. 59: where the texts differ

textually similar (0.949) · 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. 63 and IVDR Art. 59 are textually similar: their words match at a ratio of 0.949, where 1 is identical text. That says nothing about what either provision requires, or whether one should change because the other did.

Medical Devices Regulation Art. 63 on EUR-Lex (external, EUR-Lex) · IVDR Art. 59 on EUR-Lex (external, EUR-Lex)

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.

Passage	Medical Devices Regulation Art. 63	IVDR Art. 59
1	Article 63 Informed consent 1. Informed consent shall	Article 59 Informed consent 1. Informed consent shall
2	her decision to participate in the clinical investigation. 2. Information given to the subject	her decision to participate in the performance study. 2. Information given to the subject
3	implications, risks and inconveniences of the clinical investigations; (ii) the subject's rights and guarantees	implications, risks and inconveniences of the performance study; (ii) the subject's rights and guarantees
4	the right to withdraw from the clinical investigation at any time without any resulting	the right to withdraw from the performance study at any time without any resulting
5	(iii) the conditions under which the clinical investigations is to be conducted, including the	(iii) the conditions under which the performance study is to be conducted, including the
6	of the subject's participation in the clinical investigation; and (iv) the possible treatment alternatives,	of the subject's participation in the performance study; and (iv) the possible treatment alternatives,
7	participation of the subject in the clinical investigation is discontinued; (b) be kept comprehensive,	participation of the subject in the performance study is discontinued; (b) be kept comprehensive,
8	is appropriately qualified under national law; (d) include information about the applicable	is appropriately qualified under national law; and (d) include information about the applicable
9	compensation system referred to in Article 69; and (e) include the Union-wide unique single	compensation system referred to in Article 65; (e) include the Union-wide unique single
10	the Union-wide unique single identification number of the clinical investigation referred to in	the Union-wide unique single identification number for the performance study referred to in
11	unique single identification number of the clinical investigation referred to in Article 70(1) and	unique single identification number for the performance study referred to in Article 66(1) and
12	clinical investigation referred to in Article 70(1) and information about the availability of	performance study referred to in Article 66(1) and information about the availability of

8 more passages not shown; read both on EUR-Lex.

Aligned sub-provisions

Medical Devices Regulation first, then IVDR, each with its word ratio.

Art. 63(1) and Art. 59(1) · 0.988
Art. 63(1)(1) and Art. 59(1)(1) · 0.988
Art. 63(2) and Art. 59(2) · 0.925
Art. 63(2)(1) and Art. 59(2)(1) · 0.925
Art. 63(2)(1)(a) and Art. 59(2)(1)(a) · 0.915
Art. 63(2)(1)(a)(ii) and Art. 59(2)(1)(a)(ii) · 0.956
Art. 63(2)(1)(a)(iv) and Art. 59(2)(1)(a)(iv) · 0.905
Art. 63(2)(1)(b) and Art. 59(2)(1)(b) · 1.000
Art. 63(2)(1)(c) and Art. 59(2)(1)(c) · 0.977
Art. 63(3) and Art. 59(3) · 1.000
Art. 63(3)(1) and Art. 59(3)(1) · 1.000
Art. 63(4) and Art. 59(4) · 1.000
Art. 63(4)(1) and Art. 59(4)(1) · 1.000
Art. 63(5) and Art. 59(5) · 1.000
Art. 63(5)(1) and Art. 59(5)(1) · 1.000
Art. 63(7) and Art. 59(7) · 0.962
Art. 63(7)(1) and Art. 59(7)(1) · 0.961

Changes since the texts were paired

The record holds no change to either provision after the versions they were paired on.