German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported
The European Commission needs to be faster and more efficient in its implementation of the new EU Medical Device Regulation (MDR), say German manufacturers, watching the remaining months of transition time slip into single figures. A few economic operators have come clean about the pressure the MDR has brought to bear, but the suspicion is that many are choosing to keep quiet.
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There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.
The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?
The European MedTech Forum’s CEO panel set out to address high-level global, long-range issues, but from the start it got log jammed in regulatory issues. Not in the script perhaps, but wholly understandable, as new EU regulations will have huge strategic importance for how companies do business – and in the case of start-ups, if they can continue to do business.