Medical Devices in UK and EU: the regulatory framework

Medical devices are products or equipment that are used for diagnosis, prevention, monitoring or treatment of diseases, injuries or disabilities. They range from simple bandages and thermometers to complex implants and scanners. Medical devices are subject to strict regulations to ensure their quality, safety and performance.

The UK regulatory framework for medical devices originates from EU directives, which were transposed into UK law by the Medical Devices Regulations 2002 (UK MDR 2002). These regulations implemented the following EU directives:

– Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
– Directive 93/42/EEC on medical devices (EU MDD)
– Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

The UK MDR 2002 provided for a system of conformity assessment, which enabled manufacturers to place compliant medical devices on the UK market. The conformity assessment involved verifying that the device met the essential requirements for safety and performance, as well as other applicable standards and specifications. Depending on the risk class of the device, the conformity assessment could be carried out by the manufacturer themselves or by a third-party organisation called a notified body.

The UK MDR 2002 also required manufacturers to register their devices with the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for enforcing the regulations and ensuring the quality and safety of medical devices in the UK. The MHRA also oversees the post-market surveillance and vigilance system, which involves collecting and analysing data on the performance and adverse events of medical devices in use.

However, since 1 January 2021, following the end of the Brexit transition period, the UK regulatory framework for medical devices has changed. The UK is no longer part of the EU single market and customs union, and therefore no longer bound by EU law. This means that there are different rules for placing medical devices on the market in Great Britain (England, Wales and Scotland), Northern Ireland and the EU.

In Great Britain, a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the market. The UKCA marking indicates that the device conforms to the UK MDR 2002, as amended by The Medical Devices (Amendment) (EU Exit) Regulations 2021. These regulations introduced some changes to align with the new EU regulations on medical devices (EU MDR) and in vitro diagnostic medical devices (EU IVDR), which came into force in May 2021 and May 2022 respectively.

The UKCA marking can be obtained by following a similar process as before, but using a UK-approved body instead of a notified body. The UK-approved bodies are designated by the MHRA to carry out conformity assessments for medical devices in Great Britain. The MHRA also maintains a database of UK-approved bodies and UKCA-marked devices.

The UKCA marking is not recognised in Northern Ireland or the EU, so manufacturers will need to use other routes to access these markets. In Northern Ireland, due to the Northern Ireland Protocol, EU law continues to apply to goods placed on the market. This means that manufacturers will need to comply with the EU directives or regulations, depending on when they place their devices on the market, and use CE marking or CE UK(NI) marking to indicate conformity. The CE marking can be obtained by using either an EU notified body or a UK notified body that has been recognised by the EU under Article 7(4) of Regulation (EU) 2019/515.

In addition, manufacturers based outside Northern Ireland will need to appoint an authorised representative or a responsible person based in Northern Ireland or the EU to act on their behalf. The authorised representative or responsible person will be responsible for registering the device with the MHRA or an EU member state authority, depending on when they place their device on the market.

The CE marking is also required for placing medical devices on the EU market. Manufacturers based outside the EU will need to appoint an authorised representative based in an EU member state to act on their behalf. The authorised representative will be responsible for registering the device with an EU member state authority and ensuring compliance with the EU regulations.

The regulation of medical devices in the UK and the EU is complex and evolving. Manufacturers should keep up to date with the latest guidance from the MHRA and other relevant authorities, and seek professional advice if they are unsure about their obligations.