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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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Medical Device Regulation - Getting Started Soon

If you are currently selling or are looking to sell a medical device in Europe, you should have heard about the big industry news: the European Union has officially repealed the Medical Devices Direct [MDD, 93/42/EEC] and the Active Implantable Medical Device Directive [AIMDD, 90/385/EEC] and replaced it with the Medical Device Regulation (MDR). The MDR was officially published 05 May 2017 and must be implemented by medical device manufacturers by May 2020 (grandfathered companies have until 2022). Even if this date seems far off, do not push the transition off for too long. While there are many similarities between the former directives and the new MDR, there are also a great amount of chan

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