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

UsernamePublicRestriction

How The MDR Is Making The EU Competitively Backward

Executive Summary

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.

You may also be interested in...



Why The Commission Had No Choice But To Propose New Transition Periods For The EU IVDR

While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.

European Commission Gives In On IVDR Delays: Proposal For New Transition Periods

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

TEAM-NB Training Sessions Aim To Harmonize Best Practice At Time Of Rapid Change

With new EU medtech regulation in place, demand for qualified and well-trained staff at notified bodies is at an all-time high. As an abundance of new auditors are faced with a steep learning curve ahead, moves are afoot to harmonize practices.

Topics

UsernamePublicRestriction

Register

MT144473

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