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Europe

Set Alert for Policy and Regulation - Europe

EU To Join Countries Covered By India’s Clinical Investigation Waiver Rule

Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.

Clinical Trials India Europe
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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.   

EU Germany

Sir Andrew Dillon Standing Down As Head Of England’s NICE After 20 Years

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.

Health Technology Assessment United Kingdom

Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

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.

United Kingdom Australia

Raine To Lead UK MHRA Ahead Of Permanent Head Announcement

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.

Regulation United Kingdom

IMQ Appointment As Fourth Notified Body Under MDR: Good News But Big Questions

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.

Medical Device Europe

Italian Notified Body IMQ Is Likely To Be Next In Line For Official Designation

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.

EU Regulation
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