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

EU Negotiators Make Headway Toward New Device ‘Scrutiny’ Mechanism

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



New European Regulations Could Be Made Public In August

Device and diagnostics companies could get a look at the future regulatory realties in Europe as soon as August if EU policy-makers maintain current progress on negotiating new broad-reaching regulations.

Reprocessing Provisions Could Be Dropped To Ensure Timely EU Reform Resolution

Sources close to ongoing talks on European regulatory reforms say it's possible that policy-makers could decide to drop sections of proposed regulations addressing EU-wide policies for single-use device reprocessing to speed the overall path to resolution.

EU Parliament’s Public Health Committee Debates Device Reform Proposal

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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034626

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