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

What's Next For Notified Bodies: TEAM-NB President Discusses Challenges Ahead

Executive Summary

A Q&A with Guy Buijzen, of TEAM-NB, on where things stand for notified bodies right now as the EU moves to adopt the new regulations for devices and diagnostics. The EU notified body association is redoubling efforts to prepare its members for the coming changes.

You may also be interested in...



Notified Body Numbers Continue To Fall

The number of notified bodies in the EU medtech arena continues to drop, as predicted, as the tougher new requirements for these organizations take hold. Here's a look at the country-by-country details.

New Regs Lead EU Notified Body Association To Suspend Code-Of-Conduct Audits

TEAM-NB needs to redirect resources from notified body oversight toward helping its 22 members fall into line with requirements under the forthcoming Medical Devices Regulation and IVD Regulation. So what does this mean for TEAM-NB non-members and future notified body numbers?

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104169

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