French Government Will Tell Commission To Give Notified Bodies Time To Process All Files
Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.
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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.
Italy Establishes National Competencies Under Medical Device and IVD Regulations
EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.
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?