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

Proposal For EMA To Provide Medtech Expert Panel Structure Gains Traction

Executive Summary

The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.

You may also be interested in...



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

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.

How To Comply With New Requirements For Companion Diagnostics Under IVDR

The regulation of companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.

Notified Bodies Urge Companies To Pay Attention To Vague Implant Card Rules

Due to a lack of clarity in the MDR wording around which devices should be accompanied by implant cards, there is a risk companies may not supply them when patients would benefit. TEAM-NB offers guidance.

Topics

UsernamePublicRestriction

Register

MT144089

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