UK Update: Increased UK-Approved Body Capacity

By Karen Hill

The start of 2024 has seen a flurry of activity from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) regarding medical device legislation.These updates have greatly increased the UK’s capacity to certify medical devices.

Since the publication of the UK regulatory roadmap (January 9), there have been several significant updates to the list of UK-approved bodies for medical devices, including two new UK-approved bodies being added and two existing UK-approved bodies with their scope expanded.

UK approved bodies

A UK-approved body is an organization that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Manufacturers can apply to any UK-approved body, and once they have the necessary certification, their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the UK-approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.

Although UKCA marking has been available for use in Great Britain from January 1, 2021, CE marking will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met. Medical devices compliant with EU legislation continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation with which it complies. The latest of these deadlines is June 30, 2030. Full details of these transitional arrangements were published in June 2023.

New designations

LNE-GMED and Scarlet NB have now been added to the list of seven previously designated UK-approved bodies, bringing the total number to nine. Both have been designated as UK-approved bodies to assess and certify general medical devices in accordance with Part II of the UK MDR 2002, while UL International has also been designated to assess and certify general medical devices in accordance with Part IV of the UK MDR 2002, and TÜV SÜD have added active implantable medical devices to their scope.

The full list of currently designated UK-approved bodies, along with their approved designations is included in this table.

Concluding remarks

The MHRA continues to expand its capacity to review the UK MDR 2002 in preparation for the revised UK legislation (statutory instrument) expected to be released in 2025.