Notified Body Capacity; Serious Deterioration and Risk to UK Patients and Manufacturers
Dear member,
I wanted to alert you to activity the Association is undertaking regarding the capacity of notified bodies to serve our industry.
Overview
- With just nine months to go before the end of the new Medical Device Regulation (MDR) transition period, only two notified bodies (BSI-UK and TUV-SUD) have been designated to accredit and certify manufacturers placing products on the market. This is creating serious capacity constraints in the system.
- The situation has been exacerbated following the withdrawal from the medical device space by Lloyd’s Register Quality Assurance Ltd. (LRQA) and the Swiss notified body QS Zurich. This has dramatically increased the potential for products not being CE Marked beyond May 2020, despite the fact that most manufacturers are ready for the transition.
- The LRQA decision is particularly challenging for our indigenous industry, as it serves around 100 UK companies, who are now effectively orphaned from their notified body. We believe that the number of overseas companies affected is similar. The capacity constraints also mean that being able to transfer to a new notified body is far from straightforward. There is a real possibility that some of these companies could go out of business as a result.
- The situation is threatening the investment from overseas companies in not just the UK, but across the EU more widely.
ABHI response
ABHI regards the current situation as a crisis and is responding accordingly. We are in contact with our sponsoring Ministers and the MHRA and are seeking urgent measures to mitigate against the risk of companies being unable to place products on the market after May 2020 as a result of notified body capacity. We have also requested that the UK Government makes representation to the European Commission seeking a pause / extension of the MDR transition period.
If you need any further clarification, please do not hesitate to contact us.
