On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs.
This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force.
MedTech Europe’s press release can be found on their website and aligns with the views of BIVDA.
