UK Approved Bodies Medical Devices

In the UK, medical devices must be assessed and certified by an UK Approved Body before they can be marketed in the territory.

What is a UK Approved Body?

A UK Approved Body is an organisation designated by the UK health authority, the Medicines and Healthcare products Regulatory Agency – or MHRA – to assess whether manufacturers and their medical devices meet the required standards set out in the UK Medical Devices Regulations 2002 – also known as UK MDR 2002. They are responsible for certification, which allows manufacturers to place the UKCA marking on their products, thereby permitting them to be sold in England, Wales, and Scotland

The Role of UK Approved Bodies

Approved Bodies carry out various tasks depending on the classification of the products concerned. But typically, the role encompasses

• Quality assurance
• Examination of the design
• Type examination
• Verification
• Production and product quality assurance
• Audits of manufacturers to ensure ongoing compliance

How to Find an Approved Body

Manufacturers looking for a UK Approved Body to certify their medical devices can find a list of approved bodies based in the UK below.

List of UK Approved Bodies for Medical Devices

Below is a list of UK Approved Bodies that have been designated to assess and certify medical devices in accordance with the UK MDR 2002. These bodies have been accredited by the Medicines and Healthcare products Regulatory Agency (MHRA) and are regularly monitored to ensure they continue to meet the requirements for designation.

1. BSI Assurance UK Ltd
2. DEKRA Certification UK Ltd
3. Intertek Medical Notified Body UK Ltd
4. SGS United Kingdom Limited
5. TÜV Rheinland UK Limited
6. TÜV SÜD BABT
7. UL International (UK) Ltd

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Do you sell medical devices in the UK? Medical Devices manufacturers require a UK Authorised Representative to sell in the UK.