European Parliament votes to amend IVDR and MDR

Posted on 16.05.2024

The European Parliament has adopted measures to amend the In Vitro Diagnostics Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR).

This amendment includes an extension to the IVDR transitional provisions and a significant new notification requirement for critical devices. It also enables earlier use of certain European medical devices database (EUDAMED) modules.

The European Commission issued a press release following the European Parliament vote, which may be read here. The Council of the EU still needs to formally vote to adopt these measures, although they have already signalled that their vote will be positive.

The Council vote is expected to take place before the end of May, after which the proposal will be published in the EU Official Journal and will enter into force.

For more information, please contact Petra Zoellner, Director Regulatory Affairs (IVDR & MDR).