In Vivo 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

Preparing for unannounced EU regulatory inspections – are you ready?

This article was originally published in Clinica

Executive Summary

Unannounced visits from notified bodies are going to be part of life for medtech manufacturers in the EU. But do you know how you would cope if two inspectors walked through the door, expected your staff to host the visit and your testing equipment to be dedicated for their immediate use? Do you know what costs you would have to bear? Here, Gert Bos* and Francoise Schlemmer* of notified body association TEAM-NB explain why it is critical that manufacturers and subcontractors practice and validate protocols for hosting such visits

You may also be interested in...



Some Annex XVI Products Likely To Be Delayed, Updated European Commission Rolling Plan Suggests

The European Commission has updated its rolling plan. It now looks as if current member state rules for non-medical products could persist beyond the 26 May 2021 deadline.

European Commission Formally Pledges Eudamed Modules On Rolling Basis

A formal notice ends the debate over the legality of making modules of the new Eudamed 3 medical device database available as soon as they are ready.

Call For Centralized European Agency For Designation And Surveillance Of Notified Bodies

Notified bodies should now be regulated centrally in Europe rather than by individual EU member states. That is the view of one of Europe’s most experienced notified body experts.

Topics

UsernamePublicRestriction

Register

LL065251

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