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European Parliament votes to amend IVDR and MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

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.