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Leeanne Baker, managing director and quality & regulatory consultant at IMed Consultancy delves into the essential steps required for US companies to successfully enter the UK medtech market while understanding the unique regulatory landscape and market access intricacies.
In an increasingly interconnected global economy, the medtech industry plays a pivotal role in transforming healthcare and improving patient outcomes. For businesses in the medical device sector, accessing new markets and complying with diverse regulatory frameworks are essential steps towards growth and success. With the complexities and delays caused by the staged roll-out of the European Medical Devices Regulation (MDR), many US-based companies are now looking towards the UK for faster access to market. The UK has consolidated regulations and a supportive medtech strategy, making it an attractive destination for businesses seeking to expand their reach.
The UK regulatory landscape
As the dust settled after Brexit, the UK regained control over its regulations, paving the way for the development of a unique regulatory landscape separate from the EU MDR. In the interim, the UK is still operating on its previous, consolidated, tried-and-tested regulatory framework. Another key advantage of the UK market is its recent launch of a medtech strategy, demonstrating the nation’s commitment to fostering a thriving medical technology sector. The strategy aims to ensure that social care systems in the UK have reliable access to safe, effective, and innovative medical technologies. By positioning itself as an ideal market for novel and niche products, the UK encourages businesses to consider it as a launchpad for their innovative medical devices.
MHRA and UKRP: the key players
Central to the UK’s regulatory landscape are two key entities that US businesses must familiarise themselves with: the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Responsible Person (UKRP). The MHRA acts as the UK’s independent regulatory authority, responsible for overseeing the medical devices market. It plays a crucial role in safeguarding public health by ensuring the safety, quality, and efficacy of medical devices available in the UK. The MHRA conducts market surveillance and has the authority to make decisions regarding the marketing and supply of medical devices in the country. On the other hand, the UKRP serves as a vital intermediary for businesses based outside the UK. Appointed by manufacturers, the UKRP carries out essential tasks on their behalf to facilitate successful device placement in the UK market. The UKRP plays a central role in liaising with regulatory authorities like the MHRA and ensuring compliance with UK regulations.
Understanding UKRP responsibilities
Selecting the right UKRP is a critical step for businesses seeking market access in the UK. The UKRP is legally responsible for the devices they represent, putting them on par with manufacturers. To ensure a smooth market entry process, companies should be aware of the following key responsibilities of UKRPs, detailed in the U.K. MDR 2002:
- Collaborating and liaising with the MHRA on behalf of the device manufacturer to ensure compliance with UK regulations.
- Ensuring all technical documentation, including the declaration of conformity, is accurately prepared and readily available for regulatory purposes.
- Maintaining permanent copies of relevant documentation, such as certificates and declarations of conformity, as mandated by UK regulations.
- Promptly informing the manufacturer about any complaints and reports received from healthcare professionals, patients, and users related to the medical devices.
A well-chosen UKRP can make a significant difference when it comes to placing and maintaining a new medical device in the UK market. Businesses based outside the UK should carefully evaluate potential UKRPs and ensure they meet the requirements set out in the UK MDR 2002 to receive the necessary support.
Preparing for future regulatory changes
As the UK navigates its post-Brexit regulatory landscape, businesses planning to enter the UK market should be prepared for upcoming changes in the UK MDR text. Manufacturers should consider appointing UKRPs with an in-depth understanding of the medical devices regulatory landscape and expertise in dealing with institutions and volatile regulatory environments. Many medical device businesses are choosing to partner with consultancies that provide access to a team of regulatory experts, equipped with the knowledge and resources needed to support them in placing their devices on the UK market while maintaining compliance over time.
The United Kingdom’s medtech market offers a promising opportunity for businesses seeking growth and market access. With its consolidated regulations, commitment to fostering innovation, and a supportive NHS procurement system, the UK presents a favourable landscape for companies with novel and niche medical devices. To succeed in the UK market, US businesses must understand the nuances of UK regulation, appoint a reliable UKRP, and stay informed about upcoming regulatory changes. By doing so, they can position themselves for success and forge lasting partnerships within the British dynamic medtech industry. As the global healthcare landscape continues to evolve, entering the UK market holds significant potential for US companies to make a lasting impact on patient care and industry advancement.
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