Scrip 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

UsernamePublicRestriction
UsernamePublicRestriction

UK regulator calls for EU committee to assess unforeseen risks/notified body responsibilities

This article was originally published in RAJ Devices

Executive Summary

Any discussion concerning the revision of medical device legislation in the European Union should include a careful assessment of measures that are intended to make devices safer but which may have undesirable repercussions that could threaten patient safety in an unanticipated way. This was the advice of senior UK device regulator Steve Owen when he spoke at the Medtec 2010 conference in Birmingham last month.

You may also be interested in...



99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

11 Notified Bodies Under MDR Now As Ireland’s NSAI Is Officially Designated

With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.

Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race

In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.

UsernamePublicRestriction

Register

SC096096

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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