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

Unannounced notified body visits for combination products: tips on how to prepare

This article was originally published in Clinica

Executive Summary

There is much speculation as to how the new EU regulatory structure for high-risk devices, including device/drug combinations, will pan out, and how soon the new regulations will take effect. However, there is a more urgent matter for manufacturers of these products to attend to: the tighter regulatory environment that will result from the new European Commission rules – adopted at the end of September – on the designation and oversight of notified bodies, and on audits conducted by notified bodies.

You may also be interested in...



MDR Delay: Is It All Good News Or Does It Bring Its Own Problems?

In responding to industry’s plea for more time to comply with the EU’s MDR, the European Commission’s proposed one-year delay may also create some unwelcome repercussions for manufacturers and notified bodies.

New EU Rules Allow Buyers To Procure COVID-19 Devices ‘Within Hours’

With hospitals throughout the EU short of urgently needed COVID-19 medical supplies, including respiratory equipment, there are ways for companies to sell and deliver their products quickly.

Notified Body Expert Akra Calls For Special Taskforce Measures To Oversee New COVID-19 Products

With many non-CE marked products being allowed onto various EU member state markets, who is going to monitor compliance? TÜV-SÜD’s Bassil Akra calls for cooperation to avoid unsafe products being used on patients.

Topics

UsernamePublicRestriction

Register

MT101140

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