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UK Capacity to Certify Medical Devices Almost Doubles

The UK's capacity to certify medical devices has been bolstered by the addition of three more approved bodies.

The move is expected to almost double the current capacity, allowing patients to access more effective products.

Approved bodies are appointed by the Medicines and Healthcare products Regulatory Agency (MHRA) to determine whether manufacturers and their medical devices meet the requirements set out in The Medical Devices Regulations 2002.

TUV SUD, Intertek, and TUV Rheinland UK have been added to the MHRA's list.

They will look at the quality and design of a device, as well as verifying each unit or batch.

Approved Bodies "Play a Critical Role"

TUV SUD and Intertek, whose headquarters are in Munich and London respectively, will be responsible for assessing and certifying general medical devices in accordance with part two of the UK Medical Devices Regulations 2002.

TUV Rheinland UK, based in Warrington, will also assess and certify general medical devices, as well as in-vitro diagnostics.

Dr Laura Squire, MHRA chief healthcare quality and access officer, said: "By almost doubling capacity for medical device assessment in the UK, we're supporting patients to access the safe and effective products they need to protect their health. Approved bodies play a critical role in the supply of medical devices and expanding capacity has been a key priority for us to support manufacturers to bring their products to the UK."

The three new members join four existing companies on the MHRA's list of approved bodies.

They are DEKRA Certification UK, BSI Assurance UK, SGS United Kingdom, and UL International.

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