COVER STORY
ARE YOU PREPARED?
AS THE DEADLINE FOR EUROPEAN MEDICAL DEVICE REGULATION (EU MDR) IS RAPIDLY APPROACHING, OUR EDITOR LAURA HUGHES PROVIDES A BRIEF SUMMARY OF THE REGULATION AND SHARES THE RESULTS OF MPN’S RECENT SURVEY. WHAT IS EU MDR? EU MDR is scheduled to come into effect in EU Member States from 26th May 2020. This regulation will apply to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety. IS THERE POTENTIAL FOR EU MDR TO BE DELAYED? The United States issued a statement to the World Trade Organisation (WTO) in 2019 writing: “Our industry is worried about their continued access to the EU’s $125 billion USD medical device market, $20 billion USD of which is supplied by US products.” However, the EU commented in July 2019: “There are no grounds for the time being to explore any amendment to the transitional periods.”
WHERE ARE WE NOW? To date the European Commission (EC) has designated nine Notified Bodies (NBs) against MDR. The EC previously predicted at least 20 NBs. The EU acknowledged that the final number of designated NBs could be “slightly lower” than originally anticipated. The US statement to the WTO explained how they do not believe this number is enough to, “ensure continued regulatory approvals by May 2020.” Only one of the regulations that has been put forward has been adopted to date. This regulation involves the reprocessing of single-use medical devices. Additionally, the EC’s draft standardisation has been heavily criticised. The US statement addressed the issue to the WTO stating: “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.” COMMENTS Lots of key industry figures have shared their views on the topic. Reiner Thiem, head of regulatory affairs, Raumedic “We have intensively worked over the last three years to gain an understanding of the new regulatory landscape.” Peter Rose, managing director - Europe at Maetrics, a life sciences consultancy firm: “Three year transition periods are well established in our industry, but never have I seen a transition period being used to get the system ready.”
MPN CONDUCTED A SURVEY ON PEOPLE SELLING MEDICAL DEVICES WITHIN EUROPE. THE RESULTS OF THE SURVEY ARE DISPLAYED BELOW. The survey was completed by people from the following countries:
Q Did you use any consultancy service as part of your preparation?
50% 40% 10%
N/A
2%
2% 2%
2%
2% France
15%
Spain UK
Canada
USA
14
2%
32%
YES NO
2%
Germany
39%
Poland Ireland
Greece
Unknown
