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

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in SRA

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...



Device Week, 20 February 2020 – Industry Concerns Grow As Clock Is Running Out On EU MDR

With fewer than a hundred days left before the EU Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss in this week's podcast growing concerns by medtech industry members that they may not be ready in time to comply with the regulations and may inadvertently run afoul of them.

Will Switzerland’s Only EU Notified Body Survive Swixit Threat?

What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?

Medtech Biggest Casualty In Swiss/EU Uncertainty As Worst-Case Scenario Looms

Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.

UsernamePublicRestriction

Register

MT038848

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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