When it comes to medical device regulations, it is a time of transition for a number of countries. Both the EU and the UK are in the process of making significant changes to their regulations: Europe is in fact transitioning to the new EU MDR, while the UK is bringing the UK MDR into force post Brexit. Unlike the EU, however, the UK has chosen to continue to operate with earlier, consolidated regulations for a time. This means that businesses bringing a new product to the UK can continue to use tried-and-tested pathways. In addition, the UK government is positioning the country as the ideal market for products that are novel and niche, while also promising to enhance the MedTech sector and develop it as a pillar of industry making this an ideal hub for innovative health tech.

To aid this objective, the UK government recently launched a MedTech strategy to ensure social care systems can reliably access safe, effective and innovative medical technologies[1]. The document confirms the focus on medical technology and its role within the UK health and care system, acknowledging the critical role MedTech devices have had in combatting the Covid-19 pandemic and their future role in shaping the UK health and care system.

The UK is an appealing market to U.S. businesses also due to the NHS framework, which tenders every four years increasing the chance of successfully positioning medical devices thanks to a “one provider, one payer” model that is absent in many European countries where certain purchasing decisions are made at the regional level. This fragmentation of purchasing power in Europe is also mirrored by linguistic differences, meaning that placing products in the EU typically requires translation and localization of instructions for use, technical documents and even advertising, making market entry more time consuming and investment intensive.

Join Leeanne Baker at the MedTech Regulatory Intelligence Summit, Nov. 13-14 to learn more about “Opportunities and Strategies to Overcome Perceived Challenges to Taking Your Medical Device to the UK.”

While the UK seems an ideal market for U.S. businesses wanting to place their devices in foreign markets, there are some important issues that companies will need to be familiar with to ensure they fully understand the UK regulatory landscape, and the UK Responsible Person (UKRP) regulations are one key issue companies need to understand.

What is a UKRP?

A UKRP acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their devices on the UK market and liaise with entities such as the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is an executive agency of the Department of Health and Social Care in the UK, which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

How Do I Select a UKRP?

The UKRP must be physically located in the UK. Their name and address must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed[2]. They are also legally responsible on a par with manufacturers. Their responsibilities are detailed in the UK MDR 2022[3], but can be summarized as follows:

• Liaising and collaborating with the MHRA
• Ensuring the declaration of conformity and all technical documentation have been drawn up
• Storing a copy of all relevant documentation, including a copy of the declaration of conformity and relevant certificates and making them readily accessible
• Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and other users

Appointing a single UKRP to act on their behalf is the first and most important thing businesses based outside the UK need to do to place a device on the Great Britain market as the UKRP will be your key go-between with the MHRA. This means that choosing the right partner plays a key role in determining the future success of a device in entering the market.

While previously it was more common for an importer or distributor to also act as a UKRP, the newly defined responsibilities of the UKRP require an in depth understanding of the regulatory landscape for medical devices, making it critical to entrust this role to specialists in regulations. Manufacturers should consider UKRP providers that offer experience in dealing with institutions and changing regulatory environments that can support them with both existing and future regulatory demands that may emerge in this time of transitions.

The Northern Ireland Protocol

To understand the regulatory landscape, an important distinction needs to be made between the requirements of the UK and Great Britain (England, Scotland and Wales) and Northern Ireland, because different rules apply in Northern Ireland[4] under the Northern Ireland Protocol.

The requirements for businesses wanting to enter the market in Great Britain or the UK are as follows as of January 2021:

• Registering with the MHRA
• Appointing a single UKRP for all of your devices. (This person will act on their behalf to carry out specified tasks, such as registration)
• Compliance with relevant product marking and conformity assessment requirements for medical devices

For businesses placing devices on the Northern Ireland market, where EU MDR and EU IVDR have applied since May 2021 and May 2022, respectively, the requirements are instead CE marking and the UKNI indication if a UK Notified Body undertakes mandatory third-party conformity assessment, plus registration with the UK MHRA for certain devices, including in vitro diagnostic medical devices (IVDs).

References:

[1] Gov.uk, Medical Technology Strategy

[2] Gov.uk, Regulating Medical Devices in the UK

[3] Legislation.gov.uk, The Medical Devices Regulations 2022

[4] Gov.uk, Regulating Medical Devices in the UK