Spanish AEMPS Latest To Gain Notified Body Designation Under EU Medical Device Regulation
At last, Spain has its first notified body under the MDR.
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EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.
There is a much-acknowledged urgency to ensure medtech products are certified as fast as possible, with fears persisting that delays will result in notified body bottlenecks and product shortages.
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.