The regulatory world is buzzing with change: The May 26 deadline for EU MDR compliance has passed, the In Vitro Diagnostic Regulation (IVDR) is less than a year away, and by the end of the Brexit transition period, CE marks will soon cease to be recognized in Great Britain. The result of the latter is that after June 30, 2023, manufacturers that have or want to introduce products onto the UK market will need a UK Conformity Assessed (UKCA) mark instead of a CE mark.
Continued medical device availability in Great Britain (GB) will therefore depend on companies keeping up with multiple regulatory guidelines and timelines. Up until June 2023, in England, Scotland and Wales, the UK Medical Devices Regulation (UK MDR) 2002, based on the outgoing European directives for medical and in vitro diagnostic medical devices will remain applicable. Northern Ireland will instead follow the EU’s implementation timeline, meaning the EU MDR and IVDR apply as per their respective deadlines.
To begin with, all medical devices must be registered with the Medical and Healthcare products Regulatory Agency (MHRA). The deadlines to register high and moderate risk devices were in April and August 2021 respectively. The registration deadline for low-risk devices is in December 2021.
The purpose of this article is to highlight what manufacturers need to prioritize and areas where new information may still emerge, to provide a starting point for businesses that need to familiarize themselves with the UKCA mark requirements.
New Roles: Representatives and Approved Bodies
To obtain the UKCA mark for the GB market, manufacturers based outside of the UK will need to appoint a UK Responsible person (UKRP). The UKRP is equivalent to the EU Authorized Representative and will act as the liaison between the non-UK manufacturer and the MHRA. According to the new regulations, the name and registered place of business of the UKRP need to appear on the device labeling next to the UKCA mark.
Manufacturers will also need to reach out to a UK Approved Body. Currently there are only three organizations on the list of UK Approved Bodies.1 These organizations are in place of EU Notified Bodies for the UKCA conformity assessment process. Manufacturers should plan for a timely submission, to allow the time needed to address and rectify potential issues and to account for any possible bottlenecks and delays resulting from the scarcity of appointed UK Approved Bodies. It is therefore advisable to initiate the process now, reaching out to one of the listed UK Approved Bodies and keeping abreast of new appointments. It is going to be key to closely monitor the list of UK Approved Bodies published by the UK government as more are expected to enter the UKCA market.
Compliance Risk and Effort
Complying with new regulation may become a costly business, as medical device companies seeking to sell their products in the UK and internationally will have to go through several separate regulatory processes.2 It is therefore important to assess and compare compliance risk and effort for every device, based on preparation needed, CE mark status, classification and UK regional sales.
The preliminary work, along with product portfolio reviews, will help identify overlap between MDR/IVDR and UKCA requirements, as well as any gaps in data and documentation. As the UK MDR is based on previous European directives, manufacturers may discover they have already or at least nearly met all the requirements for certain devices, meaning the regulatory burden could be reduced when it comes to achieving compliance for these products. Starting the process with these devices will thus minimize unnecessary use of resources.
Finally, this may prove to be a particularly good time to introduce a new product to the UK market, if, for example, existing EU MDR and IVDR compliance efforts align with the regulatory requirements for the device.
Keeping Up with Developments
At the end of the Brexit transition period, EU-based companies and UK importers will very likely experience increased administrative tasks, as well as possible additional complications caused by the fact that the CE mark will cease to be recognized. It is therefore essential that all involved parties are familiar with new controls and procedures and stay updated on new developments following information from relevant authorities.
With Brexit, the UK has an opportunity to promote patient and public access to medical devices by designing efficient, streamlined, UK-specific regulatory processes, and to address medical device safety concerns.3 It is therefore highly likely that the regulatory landscape will further develop during the transition period. It seems likely, finally, after a necessary initial increase in their compliance and financial burden, that companies which stay up to date with these changes should be well positioned to seize competitive advantage in the UK medical devices market.
- Gov.uk, Guidance: UK approved bodies for medical devices, Updated July 30, 2021
- Birmingham Health Partners Centre for Regulatory Science & Innovation, Mitigations for the move to the UKCA mark from 01 July 2023, March 2021
- Birmingham Health Partners Centre for Regulatory Science & Innovation. (April 2021). Opportunities and risks around future UK regulatory reform of medical devices.