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

Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them

Executive Summary

A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert comments how the EU expectations are now closer to those in the US.

You may also be interested in...



Latest European Commission Document Focuses On New Rapid Antigen Tests for COVID-19

With COVID-19 continuing to wreak havoc in the EU just as throughout the globe, the European Commission is proposing new measures that will impact antigen test availability and use

How TÜV SÜD Issues First Certificate Under EU’s IVD Regulation And Says Technical Documentation Is Key

Notified body TÜV SÜD has issued the first certificate under the EU’s IVD Regulation. The notified body has fundamental advice for manufacturers wanting to ensure their IVDs are compliant in time.

Experts Call For Unifying Measures For EU Political And Regulatory Oversight

Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.

Topics

UsernamePublicRestriction

Register

MT142578

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