Selling medical devices in the UK post Brexit

Selling medical devices in the United Kingdom can provide several opportunities for foreign companies. Indeed, the UK has a large and developed healthcare system, with a high demand for medical devices. Moreover, the UK’s ageing population and increasing prevalence of chronic diseases are driving demand for medical devices. Finally, the UK has a favorable business environment, with a well-developed infrastructure and a strong intellectual property regime, making it an attractive location for investment in the medical device sector. However, companies should also be aware of the challenges associated with selling medical devices in the UK, including regulatory compliance, price competition, and the need for ongoing product innovation.

Market Key Figures

The UK has one of the largest integrated health system in the world. Global healthcare expenditure is expected to rise at a compounded annual growth rate (CAGR) of 5% in 2019 to 2023 a year. Expenditure in the UK is rising consistently, it amounted to £225 Billion in 2020,  about 10% of GDP. A virtuous circle is emerging from being one of the largest healthcare markets, having state of the art education and training and access to capital and innovation:

• • the UK is at the forefront of research and innovation across life sciences, healthcare, medical devices, and digital technologies
  • the NHS has clear strategies to improve prevention, diagnosis, treatment, and care until the end of life
  • the UK has many world-famous hospitals and universities and a thriving private sector for healthcare, technology, training, and infrastructure
  • 70 years of an integrated, comprehensive healthcare system, rated the best in the world for patients, population, and taxpayers (Commonwealth Fund, 2017)
  • continuous innovation (such as new models of care, pioneer sites, accountable care systems)

40 hospitals will be built by 2030 as part of a package of £3.7 Billion. In addition, 20 Hospitals will receive a share of £850Million to upgrade outdated facilities and equipment

Venture Capital investments in Biotech-Pharma start-ups jumped 41% Year on Year to $5.4 Billion. The UK remained the highest deal value provider in general and reached a record $14.3 Billion in 2020, providing a third of the total in Europe. The UK remains a very attractive destination for Venture Capital investment despite Brexit.

UK Responsible Person

Brexit had two main implications for companies who wish to place their products on the UK market:

The first one is the necessity to name a UK Responsible Person (UKRP). The UKRP is responsible for registering all Medical Devices and IVD (UK MDR 2002 as amended) with the Medicines Regulation and Health products Regulatory Agency (MHRA), the British equivalent of the FDA and the EMA.

The responsibilities are as follow:

• ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
• keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
• in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
• where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
• where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
• cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
• if the manufacturer acts contrary to its obligations under these Regulations:
• terminate the legal relationship with the manufacturer; and inform the MHRA and, if applicable, the relevant Approved Body of that termination.
  
  

UKCA Marking

The second implication for companies who wish to place their products on the UK market is the necessity to acquire a UKCA marking:

• The name of the UKRP must appear on all UKCA labels.
• UKCA Marking (UK Conformity Assessed) is a conformity assessment mark used to certify products in the United Kingdom after Brexit.
• The UKCA mark certifies that a product complies with applicable British product safety, health, environmental and other relevant standards, and is intended to replace the CE marking in the UK.
• The UKCA marking is mandatory for certain products placed on the UK market after January 1st, 2022.
• The name of the UKRP must appear on all UKCA labels.
  
  
  

  Discuss with us the best strategy for marketing your medical devices in England post-Brexit