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 industry needs all hands on deck to scale back MDR scrutiny clause

This article was originally published in Clinica

Executive Summary

Recent days have seen a welter of industry association concern following the European Parliament’s ENVI committee’s vote on the EU Medical Device Regulation (MDR). And I, as the chief US lobbyist on the original Medical Device Directive (MDD, 93/42/EEC), certainly share some of their frustration and consternation.

You may also be interested in...



The Rozy View: US Medtechs Face New Reg Burdens On Entering EU Market

The EU MDR and IVDR have finally been adopted, which is good news in the sense that regulatory certainty is guaranteed, but bad news in terms of the extra compliance costs that industry, including US medtechs, will have to face in the coming years.

The Rozy View: Medtechs, Negotiate With India’s Regulators And Don't Give Up On Japan

Late to the regulatory game India's government authorities may be, but device companies need to be on their toes to not lose out on vast future market opportunities as the "Make in India" program takes shape. That is the view of international device regulatory and market access expert Ed Rozynski. And while India is on the up, is Japan losing its attractiveness?

Brazil's Anvisa thinks both big and small on medtech GMP regulatory changes

Brazil's medicines and medical devices regulatory authority, Anvisa, is not overlooking the needs of smaller device manufacturers as it moves to simplify and align its regulatory processes with those of established major countries.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT100906

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