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EU Regulations 88304 and 98709 AK Samvirke Ak Samvirke Form

EU Regulations 88304 and 98709 AK Samvirke Ak Samvirke Form

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i would like to talk to you during the next 15 minutes about the impact of the european in vitro diagnostic regulation 2017 746 on laboratory testing for rare diseases this is obviously not a very sexy topic this late on the in the evening but it is a very important topic in fact for rare disease testing the european ivd regulation is a european regulation which means that it becomes binding automatically for all eu member states on the date it enters into force this will be in may 2022 for the ivd regulation the aim of the regulation is to improve the quality of in vitro diagnostic tests just like the mdr the medical devices regulation which enters into force in may 2021 aims to improve the quality of medical devices one of the drivers in fact for the mdr and also then the ivdr were scandals such as the pip scandal in france with the breast implants the major principle of the ivd regulation is that it is important to have a stricter regulation and that as much as as possible should in

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