As the European regulatory landscape undergoes significant transitions, United States medtech businesses are increasingly turning their focus towards the United Kingdom. With the implementation of the new EU Medical Device Regulation (MDR) causing delays and complexities for companies seeking to place new devices on the European market, the UK presents an attractive alternative. Unlike the EU, the UK currently still operates with consolidated regulations for the time being. Moreover, the UK government's commitment to enhancing the medtech sector and its recently launched medtech strategy further solidify its position as an attractive destination for innovative and niche medical products.
In this guide, we will explore the appeal of the UK market for US businesses and delve into the essential concept of UK Responsible Persons (UKRPs). Understanding the UK regulatory landscape and the significance of UKRPs is crucial for any US-based medical device manufacturer aiming to establish a foothold in this promising market.
Why choose the UK market?
In Europe, the implementation of the EU MDR has led to delays and challenges in getting medical devices approved and commercialized. As a result, US medtech businesses are now looking to the UK as an alternative destination to introduce their products to the European healthcare market without facing the same complications. In contrast to the evolving and sometimes complex regulatory framework in the EU, the UK currently still operates with consolidated regulations, providing a more straightforward pathway for market entry. In addition, the UK government has recognized the importance of the medtech sector in advancing healthcare and has launched a specific strategy to support and promote the industry. 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.
Unique UK market advantages
The National Health Service (NHS) in the UK offers what is often perceived as a "one provider, one payer" model, streamlining the procurement process for medical devices. Having a single healthcare provider and payer significantly reduces the complexity of negotiating contracts and allows for better market penetration and positioning within the NHS network. Further accelerating the market access process for US companies, the UK market does not require medical device manufacturers to translate or localize their instructions, technical documents, and advertising materials, unlike other non-English speaking European countries, also eliminating the need for additional investments.
Understanding the UK regulatory landscape
To successfully enter the UK market, US MedTech businesses need to understand the UK's regulatory environment. Familiarity with key acronyms such as the Medicines and Healthcare products Regulatory Agency (MHRA) and UK Responsible Persons (UKRPs) is essential for navigating the regulatory process.
The MHRA is the UK's regulatory authority responsible for overseeing the safety, quality, and effectiveness of medical devices placed on the UK market. Compliance with MHRA regulations is essential for manufacturers to lawfully introduce their products to the UK healthcare system. As part of its role, the MHRA performs market surveillance to monitor the safety and performance of medical devices in the UK. The agency has the authority to take action on the marketing and supply of devices that do not meet the required standards.
A UKRP (UK Responsible Person) acts on behalf of non-UK businesses to carry out tasks needed to place their device on the UK market. UKRPs play a crucial role for US businesses that do not have a physical presence in the UK, ensuring compliance with UK regulations and facilitating market access. 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.
Navigating shifting deadlines
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 assessment requirements:
- UKCA marking, currently based on EU MDD, AIMDD, and IVDD, has been available for manufacturers wishing to place medical devices on the Great Britain market Since Jan. 1, 2021.
- CE marked general medical devices compliant with EU MDD and AIMDD can be placed on the Great Britain market up until the sooner date of expiry of certificate or June 30, 2028.
- CE marked IVDs compliant with the EU IVDD can be placed on the Great Britain market up until the sooner date of expiry of certificate or 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.
Choosing the right UKRP
Selecting a reliable and competent UKRP is vital for a smooth market entry process. Manufacturers should be well-informed about the requirements and responsibilities associated with UKRPs to make an informed decision. For non-UK businesses, appointing a UKRP is the initial and critical step in gaining access to the UK market. The UKRP will handle various tasks, including liaising and collaborating with the MHRA, ensuring the declaration on 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 it readily accessible, immediately informing the manufacturer about complaints and reports from the market — healthcare professionals, patients, and users in general.
Given the significant regulatory responsibilities of UKRPs, it is crucial for them to have a comprehensive understanding of the UK's medical device regulations and requirements. Manufacturers should consider UKRP providers who have a proven track record of navigating complex regulatory environments and working with healthcare institutions.
Leveraging regulatory expertise for market entry
Engaging with a consultancy that specialize in medical device regulatory affairs can provide US businesses with access to a team of experts. These consultancies can offer comprehensive support and guidance throughout the regulatory process. From regulatory strategy development to market entry planning and ongoing compliance, consultancies can be valuable partners in facilitating successful market entry and sustained growth in the UK medical device market.
With a strategic approach, adherence to UK regulatory standards, and the support of competent UKRPs, US medtech businesses can pave the way for success in the dynamic and promising UK medical device market.
Visit www.ukrp.org to find out more.