Infokiri

To: National Focal Points for Microbiology (members/alternates)

cc. National Coordinators (members/alternates)

Dear National Focal Points for Microbiology,

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) were adopted in 2017. The Regulations aim to ensure that only safe and effective devices are on the EU market, to protect patient safety and public health while supporting innovation.

Considering the extent of the changes introduced by the Regulations, transition periods were envisaged to ensure a smooth transition to the new rules. These transition periods continue to apply and due to some challenges, have been extended. In view of the significant challenges encountered in transitioning to the new rules the Commission has decided to launch a targeted evaluation of the Regulations in 2024.

As part of this evaluation the European Commission has opened a public consultation to receive feedback on the regulation and its impact.

EU rules on medical devices and in vitro diagnostics – targeted evaluation

We kindly encourage you to provide feedback on this evaluation or share the link with colleagues who have an interest in this topic and are willing to contribute. Please be advised that the deadline for submitting feedback is 21 March 2025.

Kind regards,

Daniel Palm

on behalf of the ECDC Microbiology Team