Changes to UK Medical device regulations

Medical device regulation is of utmost importance in ensuring patient safety by establishing standards for the design, manufacturing, and performance of devices. These regulations mitigate risks, enforce quality management, and necessitate thorough testing and clinical evidence submission before market approval. Standardisation, global harmonisation, and the legal framework contribute to consistency and accountability in the industry. Adherence to regulations builds trust among healthcare professionals and patients, instilling confidence in the safety, efficacy, and quality of medical devices, ultimately safeguarding public health.

The changes in the UK medical device regulations primarily stem from the country’s departure from the European Union and the regulatory framework and the end of the Brexit transition period on 31st December 2020. The introduction of the UK Conformity Assessed (UKCA) mark replaced the CE mark, emphasising compliance with UK-specific standards. The shift aims to align with global regulatory standards, particularly in enhancing post-market surveillance for improved safety monitoring. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has taken on a more independent role in regulatory decision-making, emphasising adaptability to industry advancements and a commitment to safeguarding public health and patient safety in the evolving landscape of medical device technology.

While the UK’s regulatory framework was expected to be similar to the European Union’s Medical Device Regulation (MDR) in many aspects, it was not an exact replica.

Key points to consider:

• Conformation marking:

• The UKCA marking was introduced for products placed on the UK market, while the CE marking remained relevant for the European market. The two systems were not interchangeable, and manufacturers needed to comply with the specific requirements for each.

• MHRA’s Role:

• The UK Medicines and Healthcare products Regulatory Agency (MHRA) took on an expanded role in the regulation of medical devices in the UK. The MHRA became the primary regulatory authority responsible for the approval and oversight of medical devices in the UK.

The role of the UK Responsible Person is pivotal in obtaining the UKCA mark for medical devices in the United Kingdom. The Responsible Person, designated by the manufacturer, plays a key role in the UK’s post-Brexit regulatory framework. Responsibilities include registering with the UK Medicines and Healthcare products Regulatory Agency (MHRA), maintaining and updating technical documentation, cooperating with the MHRA, and keeping records. The Responsible Person acts as a point of contact for regulatory matters, facilitating the manufacturer’s adherence to UKCA marking requirements. The UK responsible person must be either an individual British citizen resident in Great Britain, or a UK registered company with relevant experience in regulatory affairs and a sound understanding of the provisions set out in the UK MDR 2002

Special provisions for Northern Ireland

Post-Brexit, the geopolitics of Northern Ireland became particularly important, as it shares a land border with the Republic of Ireland, which remains a full EU member state. Because this border is not enforced and Northern Ireland remains part of the EU single market, free movement of people and goods can occur between the two countries.

For the EU, as part of the UK exit arrangements, medical devices placed on the market in Northern Ireland must continue to meet the same standards as those placed on the EU market. On the contrary, for the UK government, it was imperative to ensure unfettered access to the Northern Ireland market for UK businesses operating in Northern Ireland. Therefore, CE-marked products complying to EU regulations can continue to be placed on the Northern Ireland market, even after the end of the UK transition period with the UKCA marking is not an accepted mark in Northern Ireland. H