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

Expert Panel Review Likely For Just 10% To 20% Of Files Submitted

Executive Summary

Expert panel review of clinical files for high-risk devices is happening for the first time under the new EU medtech regulations. The process has begun but expert panel opinions may be rarer than many had originally expected.

You may also be interested in...



Commission Launches Expert Panel Review Of High-Risk IVDs Despite No EURL Appointments Yet

Expert panel review of clinical files for high-risk IVDs are happening for the first time under the new EU IVD Regulation.

First Expert Panel Opinion Offers Valuable Learning Opportunities

BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.

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.

Related Content

Topics

UsernamePublicRestriction

Register

MT144096

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