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


EU Parliament Considers More Stringent Medical Device Regulations

This article was originally published in The Gray Sheet

Executive Summary

EU Parliament committee continues debate on medical device regulations, focusing on pre-market approval, scrutiny of notified bodies and post-market surveillance.

You may also be interested in...

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.

Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms

The Committee held a workshop Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight. Some members of Parliament and others in Europe believe the proposal may not go far enough when it comes to pre-market oversight.

U.K. Health Dept. Recommends Stronger Adverse Event Reporting System In Wake Of Breast Implant Scandal

Internal review finds U.K. regulators were not at fault in the PIP breast implant scandal, but recommends improvements to adverse event reporting and analysis.

Latest Headlines
See All



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