Progress on the proposal for a regulation to simplify rules on medical and IVD devices

DateEventFurther information
16 Dec 2025 The EU commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devicesThe details of the Commission Proposal are discussed in this post1.
1 July 2026The Rapporteur in the European Parliament’s Committee on Public Health (SANT) published his draft report  in response to the Commission’s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).2The Draft Report contains over 130 suggested amendments to the Commission Proposal, giving an indication of what amendments the Parliament may target in the legislative process for the MDR/IVDR revision.2
References
  1. From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR, Alexander Russanov et al, 17 December 2025, BioSLice blog, Arnold & Porter.
  2. How will the EU Parliament shape the MDR/IVDR revision? Draft report indicates how Parliament may seek to amend Commission’s proposals, Fabien Roy et al, 6 August 2026, BioSLice blog, Arnold & Porter
Further reading
  1. European Commission proposes dramatic simplification overhaul of medical device and IVD rules, Jamie Hatzel et al, 19 December 2025, Bristows
  2. Radial simplification of the MDR and IVDR – An overview of the key changes in the European Commission’s proposal of 16 December 2025, Dr Enno Burk et al, 30 December 2025, Gleiss Lutz
  3. Medical devices: EU Commission proposes MDR and IVDR revision, A&O Shearman 16 April 2026