emendrixAccount

Textual twins

Medical Devices Regulation Art. 16 and IVDR Art. 16 where the texts differ

textually similar (0.994) · 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. 16 and IVDR Art. 16 are textually similar: their words match at a ratio of 0.994, 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. 16IVDR Art. 16
1

the market a device under its name, registered trade name or registered

the market a device under its own name, registered trade name or registered

2

a manufacturer as defined in point (30) of Article 2, assembles or adapts

a manufacturer as defined in point (23) of Article 2, assembles or adapts

3

the manufacturer, in accordance with Section 23 of Annex I, relating to a

the manufacturer, in accordance with Section 20 of Annex I, relating to a

4

carrying out any of the activities mentioned in points (a) and (b) of

carrying out any of the activities referred to in points (a) and (b) of

5

competent authority with a sample or mock-up of the relabelled or repackaged

competent authority with a sample or a mock-up of the relabelled or repackaged

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.