Dear members, please see the link below to the European Commission’s initial proposal to revise the EU MDR and IVDR. Please note that this is just an initial proposal and is subject to the usual EU trilogue process between the EC, the European Parliament, and the European Council. This process could take 18 months to 3 years, typically before a final draft of legislation is agreed. In addition, once published, there will be transition times that will apply. So, for the moment, if placing or transitioning products to the EU IVDR, please proceed based on the current EU IVDR legislation.
Note that we will work with MedTech Europe on the response to the proposal, and although initial feedback is positive with the general approach offered by the European Commission, the devil is in the detail and there is a lot of work to be done to ensure that any counter proposals from the European Parliament and Council are also reviewed and comments feedback and advocacy taken to reach a suitable final draft.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical
