The UK market: A land of new opportunities for medical device manufacturers

The medical device industry landscape is evolving rapidly, driven both by regulatory changes and the quest for innovation.

The new European Medical Device Regulation (EU MDR) and its implementation are causing delays and complexities for foreign companies looking to place or maintain devices on the EU market, and, as a result US businesses are increasingly turning their focus towards the United Kingdom. The UK, in fact, is still operating with consolidated regulations, providing a more straightforward pathway for market entry.

In addition to this, the government has recently launched a MedTech strategy¹ to confirm its commitment to enhancing the sector and recognising its importance to the economy. This strategy aims to encourage the development and adoption of innovative medical technologies. This streamlined approach is particularly beneficial for companies with innovative and niche medical devices that might face challenges in the broader EU market.

This article will look into the UK’s regulatory environment, addressing requirements and steps needed to place a new medical device on the British market, with a focus on the role of the UK Responsible Person (UKRP).

Streamlined procurement and the "one provider, one payer" model

A key advantage that is unique to the British healthcare system is the perceived “one provider, one payer” model offered by the National Health Service (NHS), that enables a streamlined procurement process for medical devices. This model significantly reduces the need of negotiating contracts and furthermore allows for better market penetration and positioning within the UK market via the NHS network. For US businesses specifically, choosing the UK market also eliminates language barriers. Original instructions, technical documents, and advertising materials can be used without the need for translations, providing a further incentive to consider entering the British medical devices market.

Navigating the United Kingdom’s regulatory landscape

Successfully placing medical devices on the UK market requires adherence to the regulations set forth by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is the regulatory authority responsible for overseeing the safety, quality, and effectiveness of medical devices placed on the UK market.

As part of its role, the MHRA performs market surveillance to monitor the safety and performance of medical devices in the UK. Compliance with MHRA regulations is essential for manufacturers to lawfully introduce their products to the UK healthcare system and the agency has the authority to intervene on the marketing and supply of devices that do not meet the required standards. Specifically, as of January 2021, businesses seeking to place medical devices on the Great Britain market must register with the MHRA, appoint a UKRP, and comply with relevant product marking and conformity assessments requirements, such as UKCA marking (based on EU MDD, AIMDD, and IVDD, and available since 1st January 2021), CE marking (valid to place medical devices and IVDs compliant with EU MDD and EU IVDD until the sooner date of expiry or 30th June 2028 and 30th June 30th 2030, respectively.)

The role of the UK Responsible Person (UKRP)

Appointing a UKRP is the first, non-negotiable step every foreign business needs to take in order to enter the UK market, as the UKRP serves as the primary point of contact for interactions with the MHRA and ensures that regulatory obligations are met. Beyond liaison with regulatory authorities and ensuring product compliance, UKRPs are required to ensure all documentation has been drawn up, to keep available a copy of this documentation and of relevant certificates, and to immediately inform the manufacturer about complaints and reports from healthcare professionals, patients, and users.

To be eligible as UKRPs, individuals or entities must be physically located in the UK, and their name and address must be included on the product labelling or instructions for use where UKCA marking has been applied.²

UKRP: Making the right choice

Given the pivotal role that UKRPs play in the market entry process, the selection of a dependable and experienced UK Responsible Person (UKRP) is therefore crucial for international businesses not based in the UK to ensure a seamless market entry procedure. Due to the substantial regulatory accountabilities of UKRPs, it is imperative for them to have a comprehensive understanding of the UK's medical device regulations and requirements. Manufacturers should consider engaging UKRP providers with a proven track record of navigating intricate regulatory landscapes and collaborating with healthcare establishments.

Manufacturers are turning to consultancies specialising in medical device regulatory affairs for their UKRP needs, as these can typically grant access to an entire team of specialists and offer comprehensive support and guidance throughout the regulatory journey. As the medical device industry witnesses the convergence of regulations and technological innovation, the UK emerges as a promising destination for manufacturers seeking new horizons. The UK's consolidated regulatory environment, coupled with its streamlined procurement model and commitment to nurturing MedTech innovation, position it as an attractive option for companies looking to expand their global footprint.

Ranging from the development of regulatory strategies to planning for market entry and ongoing adherence to compliance, the right partner can be invaluable in facilitating successful market entry and sustained expansion in the UK's medical device market.