Swissmedic inspects Class I manufacturers in Switzerland!

Posted on March 31, 2023 By MDSS

Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 2022. The results revealed poor performance among manufacturers, with 70% of post-market surveillance (PMS) documentation failing to meet legal standards...

News, MDR

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

Posted on March 27, 2023 By MDSS

BSI supports its clients with their own FAQ We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published. We would also like to thank our clients for their valuable feedback, which greatly contri...

News, MDR

Have your say!

Posted on March 24, 2023 By MDSS

EU proposes Master UDI for contact lenses The European Union has introduced a new initiative for a Master Unique Device Identification (UDI) Device Identifier (DI) (Master UDI-DI) for highly individualized contact lenses. The UDI system is designed to improve traceability and accountability for me...

News, MDR

Extension of the MDR for legacy devices!

Posted on March 3, 2023 By MDSS

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is MDSS’ outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official ...

Swissmedic inspects Class I manufacturers in Switzerland!

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

Have your say!

Extension of the MDR for legacy devices!

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