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German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

 
• By Ashley Yeo

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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Players in Germany, the EU’s biggest medtech market and industry base, and the one with the equal highest number of notified bodies (with Italy), are increasingly nervous about the state of readiness of the EU regulatory system for medical devices under the Medical Device Regulation (MDR, 2017/745 EU).

The national medtech industry this week repeated its concerns about the worsening bottlenecks likely to arise as a result of too few notified bodies having been designated under the MDR....

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