MDCG Listens To Industry Over New Medtech Regulation Hurdles And Publishes 19-Point Action Plan
The medtech sector will be relieved to see this latest document relating to the implementation of the EU’s Medical Device and IVD Regulation. Its concrete proposals address multiple concerns.
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The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.
The German Parliament’s Upper House wants the government to intervene when it comes to the patchy implementation of the EU's medtech regulations and slow the rapid disappearance from the market of safe medtech products at the same time as maintaining the German medtech sector.
The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this really the lifeline needed for the medtech industry?