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 IVD "Common Technical Specifications" May Spread To Certain Devices

This article was originally published in The Gray Sheet

Executive Summary

Use of the "common technical specifications" concept contained in the European Union In Vitro Diagnostics Directive could spread to certain high-risk medical devices, undermining the principle of device manufacturer self-regulation in the EU, according to Richard Moore, director-business area, European Confederation of Medical Devices Associations (EUCOMED).

You may also be interested in...

EU Commission To Issue Drug/Device Classification, Breast Implant Policies

A European Commission formal policy on classification of drug/device borderline products will be compulsory for member states, according to the commission's DG III head Joseph Putzeys.

What Lies Ahead: COVID-19 Vaccination Challenges

The director of adult immunizations at Johns Hopkins International Vaccine Access Center talks to Scrip about undertaking a massive COVID-19 vaccination effort in the US.




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