MHRA UKRP Requirements For U.S. Med Device Companies To Enter The U.K. Market

By Matthew Burton, strategic development director, IMed Consultancy

The new European MDR is causing delays and complications for businesses wanting to place a new medical device on the European market. This full regulatory transition, as well as the language barrier to entering countries that speak different languages, are causing many U.S. businesses to consider placing their devices on the U.K. market instead.

The U.K., in fact, is still operating with consolidated regulations and recently launched a medtech strategy¹ to ensure social care systems can reliably access safe, effective, and innovative medical technologies,² positioning itself as an ideal market for products that are novel and niche while trying to enhance the medtech sector and develop it as a pillar of industry with the declared objective of attracting innovative products. In addition, the U.K. market provides a “one provider, one payer model,” with tenders every four years that increase the chance of successfully positioning medical devices within the NHS framework, while in many European countries purchasing decisions are made at a regional level. Another plus side of placing a device on the U.K. market is the absence of language barriers; in contrast with Europe, where each country requires ad hoc translation and localization of instructions for use, technical documents, and even advertising, the U.K. requires minimal changes.

U.S. businesses should get acquainted with acronyms such as MHRA and UKRP, as both play a central role in the U.K. regulatory landscape.

First, we have the Medicines and Healthcare products Regulatory Agency (MHRA), the entity responsible for regulating the U.K. medical devices market. Specifically, the MHRA performs market surveillance and can make decision over the marketing and supply of devices in the U.K.

Secondly, a UKRP, or U.K. Responsible Person, acts on behalf of businesses based outside the U.K. to carry out all tasks needed to successfully place their device on the U.K. market and liaise with entities such as the MHRA. Choosing the right UKRP, especially when placing a device on the U.K. market for the first time, can definitely make the difference for medical device manufacturers. Businesses therefore need to be at least familiar with all the UKRP requirements and responsibilities as set out in the U.K. Medical Device Regulation (MDR) 2002 to ensure they are getting all the support required from an eligible UKRP.

As detailed in the U.K. MDR 2002,³ UKRPs are required to be physically located in the U.K. and their name and address must be included on the product labeling or outer packaging or the instructions for use if the UKCA marking has been affixed.⁴ They are also legally responsible for the device they represent, on the same basis as manufacturers.

A UKRP’s responsibilities can be summarized as follow:

• liaising and collaborating with the MHRA,
• ensuring the declaration of conformity and all technical documentation have been drawn up,
• keeping available a copy of all relevant documentation, including a copy of the declaration of conformity and relevant certificates permanently on hand, and
• immediately informing the manufacturer about complaints and reports from healthcare professionals, patients, and users.

Appointing a single UKRP to act on your behalf is therefore the first and most important step in placing a device on the U.K. market. The right UKRP can make all the difference when it comes to placing and maintaining a new medical device on the market, so a trusted partner, and preferably one that shares your vision, needs to be selected.

In fact, although it was not unusual for an importer or distributor to also act as a UKRP under the transitional provisions, the anticipated new requirements, as described in the U.K. Government Response on future device regulations (published June 2022), should be published in full by late 2024. The government is aiming for the core aspects of this future medical device regimen to apply beginning July 1, 2025. This text, once published, will define new responsibilities of the UKRP. Specifically, the UKRP will require an in-depth understanding of the regulatory landscape for medical devices, and manufacturers should consider appointing a UKRP that is well versed in dealing with institutions and volatile regulatory environments.

Requirements For Specific U.K. Geographies

One the important things to keep in mind when starting the process of placing a medical device on the U.K. market is the difference between United Kingdom and Great Britain. Due to Northern Ireland’s unique regulatory status, in fact, different rules apply in Northern Ireland and in Great Britain (Scotland, England, and Wales).⁵

As of January 2021, businesses wishing to enter the market in Great Britain are required to:

• register with the MHRA,
• appoint a single UKRP for all of their devices, who will act on their behalf to carry out specified tasks, such as registration, and
• comply with relevant product marking and conformity assessment requirements for medical devices.

Note:

• UKCA marking has been available for manufacturers wishing to place medical devices on the Great Britain market since January 1, 2021. UKCA marking is currently based on the EU Medical Device Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD), and the In Vitro Diagnostic Directive (IVDD).
• CE marked general medical devices compliant with EU MDD and AIMDD can be placed on the Great Britain market up until the sooner of: (a) expiry of certificate or (b) June 30, 2028.
• CE marked in vitro diagnostics (IVDs) compliant with the EU IVDD can be placed on the Great Britain market up until the sooner of: (a) expiry of certificate or (b) June 30, 2030.
• CE marked general medical devices (including custom-made devices) compliant with the EU MDR, and IVDs compliant with the EU IVDR, can be placed on the Great Britain market up until June 30, 2030.

Requirements for placing devices on the Northern Ireland market can be summarized as follows:

• The EU MDR and EU IVDR have applied in Northern Ireland since May 2021 and May 2022, respectively, whereas they are only recognised in Great Britain.
• CE marking is required in Northern Ireland. In addition, the UKNI indication is required if a U.K. Notified Body undertakes mandatory third-party conformity assessment.
• Certain devices will require registration with the U.K. MHRA, including IVDs, which need to be registered with the MHRA when placed on the Northern Ireland market.
• Non-U.K. manufacturers are not required to appoint a UKRP for the purpose of placing medical devices on the Northern Ireland market.

Visit www.ukrp.org to find out more.

References

1. Gov.uk, Medical Technology Strategy
2. Gov.uk, Medical Technology Strategy
3. Legislation.gov.uk, The Medical Devices Regulations 2022
4. Gov.uk, Regulating Medical Devices in the UK
5. Gov.uk, Regulating Medical Devices in the UK

About The Author:

Matt Burton is IMed consultancy’s strategic development director, with over 12 years’ experience in QA/RA, specializing in MDD/UKCA and EU MDR. Representing many clients as UKRP, PRRC, and with global registrations, he has worked with many devices over his regulatory career. He can be contacted at matthew@imedconsultancy.com.