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

New IVDR Notified Body Named After A Nine-Month Gap

Executive Summary

A new EU notified body has been designated under the IVD Regulation after nine months of an absence of news; but another hiatus is likely now until October.

You may also be interested in...



First Polish Notified Body Designated Under The EU's Medical Device Regulation

The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.

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.

First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145354

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