European Parliament votes to amend IVDR and MDR

On 25 April 2024, the European Parliament voted to adopt the Commission’s proposal to amend the In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746) and the Medical Device Regulation (MDR, 2017/745).

There are three provisions in the amendments:

• The IVDR transition timescale is conditionally extended by two and a half years. This will help to alleviate most of the concerns about high risk diagnostic tests.
• Manufacturers of medical devices and IVDs will need to give six months prior notice of an anticipated supply disruption.
• Parts of EUDAMED will become mandatory for medical devices and IVDs from January 2026.

The amending regulation will extend the IVDR transition timelines as follows:

• Class D: to 31 December 2027 (from 26 May 2025);
• Class C: to 31 December 2028 (from 26 May 2026); and
• Sterile Class B and Class A: to 31 December 2029 (from 26 May 2027).

A Q&A document is now expected from the Commission, akin to the Q&A for the MDR transition published last year, to help explain some of the more detailed aspects of these new amendments.