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

Europe Device Reg Reform Proposal: More Scrutiny Of Notified Bodies Expected

This article was originally published in The Gray Sheet

Executive Summary

Industry expects the European Commission to propose more oversight of notified-body reviews by member countries. But the Commission appears to have resisted calls to establish a direct government approval process for devices.

You may also be interested in...



In Europe, Contrarian VC Wellington Partners Favors Medical Devices

In September, Wellington Partners announced that it closed on €70 million ($91 million) in new venture capital, the first commitment for a fund devoted to life science investing. The target size of Wellington Partners IV Life Science Fund is €120 million, a significant increase over its previous fund devoted to the life sciences, which raised €78 million. Five years ago, this event wouldn’t even have been news, but in a world where venture capital funds are generally contracting, and specifically with regard to life sciences, Wellington offers medical device start-ups a bright spot of hope.

EU Device Reform Proposal Adds More Government Scrutiny, But No FDA-Like Review Body

The recommendation attracting the most concern from industry: a new Medical Device Coordination Group that would have the option to scrutinize third-party pre-market assessment reports for select devices prior to marketing.

International News In Brief

In wake of PIP breast implant scandal, a European Parliament committee calls for stronger device laws. More international regulatory news.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031579

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