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

Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording

Executive Summary

Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.

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

MT124666

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