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EU MDCG Q&A on Eudamed registraton for actors not covered by MDR Article 31 or IVDR Article 28

The new document by the European Commission’s Medical Device Coordination Group (MDCG) advises manufacturers of the named medical device types to wait before designing carrier labels or registering their devices in the Eudamed database.

May 26, 2021 has arrived and the European Union’s Medical Devices Regulation (MDR) now governs medical devices (including active implantable medical devices or AIMDs). This roundup provides updates on recent resources made available by the European Commission to assist in MDR compliance.

Under the European Union's Medical Devices Regulation (MDR), Switzerland is currently considered a third country for medical devices. Find out what that means for manufacturers and importers, and how to safeguard obtain the proper clearance to place European devices on the Swiss market and vice versa.

EU MDR compliance factsheet and roadmap for Class I medical device manufacturers

Finland’s Eurofins Expert Services Oy is the latest Notified Body authorized to perform activities under Europe’s Medical Devices Regulation, but rollout on some aspects of the two regulatory schemes continues to raise concerns about capacity.

Recommendations for custm-made device (CMD) manufacturers to prepare for EU Medical Devices Regulation (MDR) compliance

Recommendations for preparing for Eudamed compliance ahead of MDR and IVDR dates of application

Eudamed UDI and registration guidelines for legacy medical devices and IVDs

Expert panelists appointed across 12 sectors for EU MDR, IVDR support

UDEM becomes eighteenth Notified Body designated under the European Medical Devices Regulation (MDR)

How Article 59 may allow European market access for urgently needed medical devices without full CE Marking

The new guidance document expands on MDCG 2020-17’s advice for conducting virtual audits of medical device manufacturers during the COVID-19 pandemic.

The new documents released by the European Commission offer insights into the new system that will require Notified Body intervention for many previously self-certified IVDs, along with a fresh attempt to call for harmonized standards under MDR and IVDR.

Switzerland has yet to formalize agreement with the European Union on recognizing the Medical Devices Regulation