EU Compliance for Medical and IVD Devices

EU Proposal to simplify MDR and IVDR: what it is and why it matters

The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.

EUDAMED becomes mandatory on 28 May 2026: deadlines for actor, device, and certificate registrations

EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.

Revision of the Medical Devices Regulations in the EU

Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.

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