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Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.
Latest From Europe, Policy & Regulation
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.
Sir Andrew Dillon is stepping down from what has been described as one of the most challenging and potentially controversial roles in British public life.
There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.
June Raine has agreed to lead the Medicines and Healthcare products Regulatory Agency temporarily after the agency’s incumbent chief executive steps down in September.
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.
While the push for transparency was uppermost in the mind of the European Commission when it drafted the new Medical Device Regulation, the way we are learning about new notified bodies is far from transparent.
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