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


EU Parliament’s Public Health Committee Debates Device Reform Proposal

This article was originally published in The Gray Sheet

Executive Summary

Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.

You may also be interested in...

EU Negotiators Make Headway Toward New Device ‘Scrutiny’ Mechanism

The three power centers in the European Union government have come close to alignment on a plan for a more centralized premarket "scrutiny" mechanism for medical devices in ongoing talks, according to sources. The same progress has apparently not been made for in vitro diagnostics yet.

EU Policy-Makers Set End-Of-Year Goal To Finalize Device, Dx Reform

The first of five "trilogue" meetings between the European Parliament, the Council of the European Union and the European Commission to reach a settlement on broad-reaching EU device and diagnostics regulatory reforms took place Oct. 13

European Parliament Committee Proposes Enhanced Device Reg Reforms

The Internal Market and Consumer Protection Committee approved amendments to the EU Commission’s proposal. The package includes tougher pre-market regulation and more stringent scrutiny of notified bodies compared to what the Commission floated last year.

Related Content





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