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More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews

 
• By Amanda Maxwell

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.

Businessman comparing two documents, neutral background
Role Proposed For Comparing Evidence With Previous Assessments

There is more demand for notified body services than supply in the context of the EU’s Medical Device Regulation, so anything that can be done to make assessments go more smoothly and quickly will be in the interest of industry, notified bodies and patients. This is especially so as the bottlenecks grow towards the 26 May 2024 deadline for legacy products to demonstrate compliance with the MDR.

The EU’s medical device notified body association, TEAM-NB, has published a position paper which, among other things, lists what...

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