EU Now Boasts 27 MDR Notified Bodies With Latest Italian Designation
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.
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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.
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.