Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Compromise Sought On Device Reform Proposal In European Parliament Committee

This article was originally published in The Gray Sheet

Executive Summary

Dagmar Roth-Behrendt, the legislator shepherding medical device reform legislation in the European Parliament, says she wants to work with the European Commission to establish a heightened market-access standard for high-risk devices, even if it falls short of her proposal for a full PMA-like review.

You may also be interested in...



Regulatory News In Brief

IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.

News In Brief

Boston Scientific acquires C.R. Bard’s electrophysiology business. European Council issues a progress report on device reforms. More news in brief.

Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament

A key legislator on device reform in the European Parliament has issued a strong call to establish pre-market authorization for high-risk devices in Europe, among other consequential regulatory changes.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT032106

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