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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

New guidance sheds more light on medical device regulatory compliance, UK REP role

December 2020 deadline for actor registration module of the Eudamed European medical device and IVD database

Recommendations for meeting "sufficient clinical evidence" requirements as part of European MDR compliance

EC factsheet lists types of medical device, IVD information required by MDR to made public via Eudamed or other channels

Some manufacturers that want to show conformity to IEC 62366-1:2015 for user interfaces of devices may qualify for UOUP designation

New legislation is being rolled out in stages to match changing European regulations and prepare the ground for a Mutual Recognition Agreement.

Fourteen Notified Body designations to European MDR now entered into NANDO database

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of...