Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EU’s First IVDR Expert Panel View Published

Executive Summary

The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.

You may also be interested in...



First EU Expert Panel Opinion Challenges Notified Body Assessment

An EU expert panel has become the first to issue an opinion on clinical evidence, providing an insight into how the scrutiny process works under the new Medical Device Regulation. It wants to see more work done on the Class III implantable product in question.

European Regulatory Roundup, May 2022: IVDR Applies And MDR Critics Clamor Loudly For Action

This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.

EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency

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.

Topics

UsernamePublicRestriction

Register

MT144750

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel