New German Notified Body Designated Under EU's MDR
Germany now has seven notified bodies under the MDR, the most designated in a single EU member state. But more are needed in the EU generally.
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Demand for notified body certification under the Medical Device Regulation is predicted to grow exponentially over the next two years. Two new organizations have been designated in 2022 already.
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.
In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.