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

EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Executive Summary

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

You may also be interested in...



European Commission ‘Will Not Delay IVDR, Nor MDR Any Further’

It seems that the medical device and IVD industries are clutching at straws if they expect the European Commission to agree to further delays in the EU medtech regulations.

UK Responsible Person, EU ARs And Northern Ireland: The View From MedTech Europe

The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.

EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears

The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.

Topics

UsernamePublicRestriction

Register

LL1129552

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