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

Reclassification of devices: lessons from joint implants case

This article was originally published in Clinica

Executive Summary

The EU needs a proper procedure for dealing with the reclassification of medical devices. That is the opinion of Steve Owen, head of European and regulatory affairs at the UK's Medicines and Healthcare products Regulatory Agency (MHRA). It comes in the light of experience over the handling, or as some would argue, mishandling, of the reclassification of hip, knee and shoulder implants from class II to class III to include a review of the design dossier.

Topics

UsernamePublicRestriction

Register

MT059188

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