Prior to Brexit, medical device manufacturers looking to distribute their products were able to do so throughout the European Union and United Kingdom under the same regulations. However, in May 2021, the UK’s medical device laws deviated from those of the EU, due to the adoption of new regulations. This presents significant challenges for medical device manufacturers looking to distribute products in both regions. What are the new regulations and how can manufacturers adapt?
Changes to the Medical Device Regulatory Landscape
The 26th of May 2021 marked the end of the transition period for the EU Medical Device Regulation (EU MDR) and sees it fully adopted across all member states. However, the UK’s medical device regulations continue to be based on the previous EU Medical Devices Directives, which was implemented in the UK as the Medical Devices Regulations 2002 (MDR 2002). Since Brexit, MDR 2002 has been amended to reflect the UK’s post-Brexit regulatory status, including clarification on how devices will be regulated under the Northern Ireland Protocol, which requires devices sold there to also comply with EU legislation. For those companies looking to retain a presence in both markets, they must adapt to these new EU regulations, while also meeting UK requirements, representing a significant increase in time and costs.
Entering the Medical Device Market in the UK
In practice, the changes mean that companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking. Devices CE marked under EU law may be sold into Northern Ireland, but not into the UK without the UKCA mark. The biggest immediate change will be for overseas companies that wish to start to manufacture and supply medical devices in the UK. They must now assign a UK Responsible Person to register with the Medicines and Healthcare products Regulatory Agency (MHRA) and act on their behalf. For non-UK based companies, finding a trustworthy partner will be key in managing this new requirement.
A Productive Partnership
Finding and appointing a suitable UK Responsible Person was the challenge recently faced by Key2Compliance, a Swedish medical device consultancy company that supports manufacturers through the full lifecycle of their products. Jan Hellqvist, CEO of Key2Complaince, explained: “A number of our clients wish to sell their products in the UK, but do not have a base in the country, and so they need to be partnered with a UK Responsible Person. We contacted June Medical as a well-established medical device company in the UK, and were able to set up a partnership with June Medical’s daughter company, Mosaic Surgical, to act as the UK Responsible Person on behalf of our clients. Formation of this collaboration has been friction-free, which is exactly what we want for our customers, and we are excited to be able to support them through this transition.”
Heather Pendlebury, QA/RA manager at Mosaic Surgical, added: “It’s extremely important to find someone in the UK that you can trust will act as your reliable representative following Brexit. We are delighted to be working with Key2Compliance and have formed a very positive working relationship which will help to make this process as smooth as possible for non-UK manufacturers.”