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 Notified Body Figures Demonstrate The Scale And Timing Of Capacity Shortfall

Executive Summary

Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.

You may also be interested in...



Akra: Time To Acknowledge EU’s Real Implementation Problems And Stop Scapegoating

Neither manufacturers nor notified bodies are to blame for delays in implementing the EU Regulations on medical devices and in vitro diagnostics. It is down to bad project management; there are ways forward through dialogue and compromise, but time is tight, Bassil Akra tells Medtech Insight.

Italy Establishes National Competencies Under Medical Device and IVD Regulations

EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.

French Government Will Tell Commission To Give Notified Bodies Time To Process All Files

Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT145421

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