December 01, 2020
Beginning on 1 January 2021, manufacturers not established in the UK and intending to place medical technology products on the UK market must register with the MHRA, appoint a UK Responsible Person to act as representative
to MHRA, and comply with new regulations pertaining to product conformity assessment and marking with the UKCA mark.
According to the European trade association for the medical technology industry, MedTech Europe, 30% of the medical technology industry’s products have been authorized for CE marking by UK Notified Bodies1. With the exit of the UK from the EU, beginning 1 January 2021 any mandatory third-party conformity assessment required for CE marking must be carried out by a Notified Body recognized by the EU2. Although the UK will continue to accept CE marked devices on the Great Britain market until 30 June 2023, manufacturers placing products on the market in the EU27 on the basis of a certificate issued by a UK Notified Body must transition to a Notified Body recognized by the EU.
Much has been written by others regarding the acute situation regarding the availability of notified bodies to meet the increased demand under the new EU regulations for medical devices and diagnostics. As of 21 October 2020, the European Commission’s update on the “state of play”3 of joint assessments of notified bodies indicates a total of 17 NBs designated to the MDR and only 4 NBs designated to the IVDR. The data on the number of applications for designations under the new EU legislation are similarly concerning. While the number of existing NBs applying for designation under the MDR is nearly 90%, only 67% of existing NBs have applied for designation under the IVDR. We can assume not all applications will progress to Joint Assessment Team final opinion and a MDCG recommendation for designation.
Three UK notified bodies for medical devices are listed on the MHRA website: BSI Healthcare (0086), SGS United Kingdom Ltd. (0120), and UL International (UK) LTD. (0843). If you are a manufacturer placing CE-marked medical products on the market in the EU27 on the basis of a certificate issued by one of these UK NBs then your choices for transitioning are limited to those NBs listed in the NANDO database4.
The European medical technology market was estimated at roughly €115 billion in 20175.
If indeed 30% of the medical technology industry’s products have been authorized for CE marking by UK Notified Bodies, then Brexit is much more than a new set of regulations to access the UK market.