In addition, aiming to bolster the MedTech sector and attract innovative products to enhance the UK health and care system, the UK government has recently launched a new MedTech strategy document.1
According to Leeanne Baker, Managing Director and Quality & Regulatory Consultant at IMed Consultancy, this manifesto confirms the vital importance of medical technology — as recently highlighted by the COVID-19 pandemic — and the critical role that these devices will have in shaping the future of the UK healthcare ecosystem.
The new British MedTech strategy is not the only element making the UK market particularly appealing for foreign manufacturers: an important role is also being played by the National Health Service (NHS) “one provider – one payer” model, with tenders every 4 years that increase the chance of successfully positioning medical devices within the NHS framework.
Additionally, unlike accessing non-English speaking European countries, entering the UK market generally does not require the translation and localisation of instructions for use, technical documents or advertising, thus saving time and additional investments.
Understanding the UK regulatory Landscape
US businesses seeking to enter the UK market during this period of legislative transition must familiarise themselves with the UK regulatory landscape and important acronyms, such as MHRA (Medicines and Healthcare products Regulatory Agency) and UKRP (UK Responsible Person).
The MHRA is responsible for regulating the UK medical devices market, performing market surveillance and making decisions regarding device marketing and supply within the UK.
The UKRP acts on behalf of businesses based outside the UK to complete all the tasks needed to successfully place their device within the UK market and liaise with entities such as the MHRA.
It is important to highlight that, in January 2021, a number of changes regarding how medical devices are placed in the market were introduced, starting with a new route to approval and product marking (UKCA marking) that requires foreign businesses to
- register with the MHRA
- appoint a single UK Responsible Person (UKRP) for all devices to conduct specified tasks, including registration
- comply with relevant product marking and conformity assessment requirements for medical devices.
Failure to meet these requirements will prevent manufacturers from lawfully placing their devices in the UK market.
Selecting the right UKRP
Choosing the right UKRP is crucial for medical device manufacturers, especially when entering the UK market for the first time; the right partner can be the make or break of success.
Foreign manufacturers must therefore be familiar with all UKRP requirements and responsibilities as per UK MDR 2002 to ensure they receive the necessary support from an eligible UKRP.2
UK MDR 2002 states that UKRPs must be physically located in the UK and their name and address must be included on the product labelling or the outer packaging — or the instructions for use in cases when the UKCA marking has been affixed.3
They are legally responsible on a par with manufacturers and have significant responsibilities, including
- liaising and collaborating with the MHRA
- ensuring that the declaration of conformity and all technical documentation are drawn up
- keeping copies of relevant documentation, including the declaration of conformity and certificates
- promptly informing the manufacturer about complaints and reports from healthcare professionals, patients and users, should there be any.
Manufacturers should also be aware that although there is nothing to prevent an importer or distributor from continuing to act as a UKRP, the newly defined responsibilities of the UKRP require an in depth understanding of the regulatory landscape for medical devices.4
Given the significance of a UK Responsible Person, manufacturers are advised to make their selection carefully and even consider relying on a consultancy with experience in dealing with institutions and volatile regulatory environments.
This strategy can provide access to a team of experts with broad knowledge and relevant resources, supporting medical device businesses in all their regulatory needs.
References
- www.gov.uk/government/publications/medical-technology-strategy.
- www.legislation.gov.uk/uksi/2002/618/contents/made.
- www.gov.uk/guidance/regulating-medical-devices-in-the-uk.
- www.ukrp.org.
