The MDR and IVDR entered into force on 26 May 2017. However, as a result of the covid-19 pandemic and the slow implementation, the date of application of the MDR was postponed. The date of application of the IVDR remained unchanged. In addition to the amended, stricter and more comprehensive requirements of the MDR and IVDR, over a hundred of interpretative documents and European legal acts have been published over the last years. Their implementation is often very time-consuming and cost-intensive for manufacturers and notified bodies. In many cases, the modifications must also be taken into account in ongoing market access procedures, which can cause delays. The designation procedures are very lengthy and ‒ despite an intensive European coordination ‒ are still not harmonised.
What needs to be done
- End regulatory overload
- Harmonise designation procedures further
- Maintain certification cycles
- Do not establish separate regulatory provisions
- Make exemptions for certain products
Download the complete Policy Sheet here
"Medical devices: Establish a stable legal framework and enable better market access"