November 16, 2022

[FEATURED] Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled at Highest Levels

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

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November 3, 2022

[FEATURED] EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

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October 22, 2022

[FEATURED] More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews 

Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.

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September 25, 2022

[FEATURED] EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble for Manufacturers

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.

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September 19, 2022

[FEATURED] EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value

Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.

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