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. A few are listed below.
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:
“Industry is increasingly becoming concerned about the timetable for the EU MDR.” He added: “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.”
Scott Whittaker, president and CEO, AdvaMed:
“The medtech industry supports the new EU regulations’ objectives to ensure the highest level of patient safety, timely access to innovation, and the trust of all stakeholders. We are now in the critical period of transitioning to the new system, which needs to be completed by May 2020 (and May 2022 for IVDs). Industry is concerned that while we are prepared, key elements of the new EU regulatory system will not be ready sufficiently ahead of these deadlines to enable industry to comply with the new rules in time. In particular, we believe the capacity of the “NBs” (approval bodies) will not be adequate to allow for the re-certification of tens of thousands of existing and new products ahead of the May 2020 MDR implementation deadline. Appropriate and urgent action by European institutions will be essential to ensuring continued access to existing life-saving and life-improving medical devices and diagnostics that hospitals, doctors, patients and families rely on every day.”
Sandi Schaible, senior director of analytical chemistry and regulatory toxicology, WuXi Medical Device Testing:
“The year of MDR is here. And device manufacturers are under more pressure than ever before. With so many questions about NBs, whether Europe will delay implementation, and EUDAMED, the uncertainty and stress is palpable. Device manufacturers, you are not alone. We’re in this together. But don’t sit idle and risk having your devices pulled from market. If you’re behind, it’s time to lean more heavily on laboratory testing partners, if they have capacity. Put your foot on the gas and approach partnerships with transparency. Being forthcoming with details and giving your lab partners visibility to forecasts, intervals, and timelines will help you make up for lost ground in these final months before the 26th May 2020 deadline.”