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Official Q&A on the extension of the MDR published!

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Extension of the MDR for legacy devices!

New Features and Improvements in EUDAMED Production v 2.10

Key Terms and Concepts in the Medical Device Regulation - Vigilance

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2023-02-24T00:00:00+01:00

It's time for EUDAMED!

National Authorities improve their vigilance systems, but that is far from harmonization.

It makes the system even more complicated if every authority creates their own reporting system. Such changes don’t make it easier to keep EU and non-EU manufacturers selling their devices in Europe. 

See the new e-service for vigilance submissions for Sweden. This website should be used for submissions until EUDAMED is mandatory for vigilance. No registration is required. 

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

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