The government state that the Medical Device Regulations (MDR) will come in to effect in May 2020, and the In Vitro Diagnostic Regulations (IVDR) in May 2022, however the United States (US) has called upon the EU to delay the implementation of MDR and IVDR by three years.
The US highlighted what it believes to be the main issues surrounding the implementation of these regulations in a statement to the World Trade Organisation committee on technical barriers to trade: “Our industry is worried about their continued access to the EU's USD 125 billion medical device market, 20 billion USD of which is supplied by US products.”
To date the European Commission (EC) has designated two Notified Bodies (NBs) - BSI UK and TUV SUD against MDR and none against IVDR. Additionally, only one regulation that has been put forward has been adopted so far; the EC issued the draft implementing regulation on the common specifications for the reprocessing of single-use medical devices in accordance with the MDR last month.
Confusion also remains surrounding the designation of NBs for which information is conflicting. The EC predict at least 20 NBs by the end of the year, however, DG Grow anticipate there to be only 12. The US believe this number is not enough to, “ensure continued regulatory approvals by May 2020. The US also state that currently, “EU standardising bodies cannot begin work on developing the standards industry may use to comply.”
Furthermore, the EC’s draft standardisation request which was posted in June received criticism and requests to reject it. The US commented: “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.”
The EU however issued a statement in July saying: “There are no grounds for the time being to explore any amendment to the transitional periods.” They added that the final number of designated NBs could be “slightly lower compared to the current situation” and that there was a possibility that the time it takes for many of these NBs to submit their applications could be extended due to the new infrastructure surrounding NBs which aims to make them safer.
Peter Rose, managing director - Europe at Maetrics, a life sciences consultancy firm, provided his opinion on the topic: “Industry is increasingly becoming concerned about the timetable for the EU MDR. Just 2 NBs are designated and one of them - BSI UK - will be pointless if we have a hard Brexit (which is looking increasingly likely by the day). 3 year transitions periods are well established in our industry, but never have I seen a transition period being used to get the system ready.
Industry and notified bodies need 3 years from when the system is ready, i.e. from when there are enough NBs, when all the implementing acts have been issued and ratified, from when all the standards are harmonised, from when the common specifications are written and published, from when EUDAMED is fully functional.
It is widely accepted that a NB will take between six-nine months to certify a device but without all of the above it’s not looking possible. [See a recent white paper published by Maetrics on class I devices]. Up-classified class I medical devices cannot even benefit from the extended transition period afforded to higher classes and must be compliant by the date of application (26 May 2020); this is looking very difficult to achieve.”
