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


EU regulators' proposals underline need for work on classification and borderline products issues

This article was originally published in SRA

Executive Summary

In an effort to control costs and streamline decision-making around the regulation of borderline and drug-device combination products in the EU, medical device regulators from member states under the aegis of the Central Management Committee have put forward two proposals for increased co-operation between competent authorities to ensure better transparency and sharing of expertise in these areas1. The proposals also aim to achieve harmonised decision-making which is currently lacking in the system.




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