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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Germany's Upper House Adds Weight To Urgent Calls To Address EU MDR/IVDR Issues
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.
Much More Is Needed, Industry Says In Response To EU's 19-Point Regulatory Action Plan
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?
European Regulatory Roundup, June 2022: Solutions Needed As MDR/IVDR Frustrations Grow
June was characterized by an intense debate focused on shortfalls in the implementation of the EU MDR and IVDR, on who is to blame and how solutions can be found, as well as by news of some regulatory progress, at last, in the UK.