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Textual twins

Medical Devices Regulation Annex IV and IVDR Annex IV where the texts differ

textually similar (0.992) · 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 Annex IV and IVDR Annex IV are textually similar: their words match at a ratio of 0.992, 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 Annex IV on EUR-Lex · IVDR Annex IV on 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.

PassageMedical Devices Regulation Annex IVIVDR Annex IV
1

EU declaration of conformity shall contain all of the following information: 1. Name, registered

EU declaration of conformity shall contain the following information: 1. Name, registered

2

mark and, if already issued, SRN as referred to in Article 31 of

mark and, if already issued, SRN referred to in Article 28 of

3

SRN as referred to in Article 31 of the manufacturer, and, if applicable,

issued, SRN referred to in Article 28 of the manufacturer, and, if applicable,

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.