EU Medtech Industry Awaits Outcome Of MDCG’s Urgent Meeting With Bated Breath
Will the EU agree that Article 97 is the way to go to avoid notified body bottlenecks in the context of the Medical Device Regulation? This matter is now being reviewed at the highest levels.
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Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.
Do all roads lead back to the reopening of the Medical Device Regulation and risk-based staggered delays as was introduced with the IVD Regulation? Medtech Insight spoke to TÜV SÜD’s Dr Royth von Hahn and BSI’s Graeme Tunbridge, about how potential solutions to MDR delays are being received.
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?