Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation

Executive Summary

A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.

You may also be interested in...



EU Offers Insight On New MDR Guidance Documents On The Horizon

The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.

European Regulatory Roundup, May 2022: IVDR Applies And MDR Critics Clamor Loudly For Action

This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.

Here At Last: A New Era For Clinical Trials In The EU

A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT145457

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

Cancel