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 Enlargement Broadens IVD Directive Electronic Labeling Concerns – EDMA

This article was originally published in The Gray Sheet

Executive Summary

FDA's interpretation of MDUFMA electronic labeling provisions will be relevant to firms looking to comply with the EU's In Vitro Diagnostics Directive, European Diagnostic Manufacturers Association (EDMA) Director General Christine Tarrajat observed April 9

You may also be interested in...



Electronic Labeling: Globally Harmonized Policy On The Horizon?

Plans by the European Commission's Medical Device Experts Group to discuss electronic labeling during its imminent meeting signals the possibility of EU policy alignment with recently enacted U.S. legislation

Electronic Labeling: Globally Harmonized Policy On The Horizon?

Plans by the European Commission's Medical Device Experts Group to discuss electronic labeling during its imminent meeting signals the possibility of EU policy alignment with recently enacted U.S. legislation

Electronic Labeling Encouraged In CDRH Blue Book Memo Outlining Means

FDA is projecting that electronic labeling provisions in the Medical Device User Fee & Modernization Act could increase the number of devices that link to the Internet

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT018228

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