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Approved Bodies are conformity assessment bodies in the United Kingdom, the equivalent of Notified Bodies in the European Union. The UK Medicines and Healthcare products Regulatory Agency (MHRA) designates an approved body that assesses the safety and conformity of certain products, including medical devices and IVD medical devices.
For which medical devices do manufacturers need an approved body?
The UKCA marking proves that products on the UK market comply with the applicable legislation. To be sold in the UK, medical devices must bear the UKCA marking from July 2024. It is possible to place CE marked medical devices in the UK only until June 2024.
A conformity assessment procedure is necessary to affix the UKCA marking on a medical device. Excluding class I medical devices without sterile or measuring functions and general IVDs, approved bodies must assess the conformity of medical devices.
How to find an approved body
The list of approved bodies is available on the MHRA website. In total, the MHRA has designated a few approved bodies. Although the MHRA is improving the country’s capacity to assess medical devices, the demand is rising fast given the upcoming deadlines in June 2024. Thus, finding an approved body can be challenging and waiting lists be long.
Obelis selects an approved body on behalf of manufacturers
With expertise and network in the field, Obelis helps manufacturers to find the right approved body. We contact different approved bodies, provide them with the necessary information on your devices (Approved Body Selection), and – when the manufacturer wishes – we present an overview of offers and timetables (Approved Body Negotiation).
If the devices are only CE marked, manufacturers need to be prepared for the 2024 deadline. Finding an approved body and ensuring a certification in time will allow the manufacturer to place medical devices and IVD medical devices on the UK market after June 2024.
Obelis UK is certified according to the international standards ISO 9001:2015 and ISO 13485:2016 for representative and consulting services.
Our regulatory affairs consultants are committed to deliver the most efficient compliance process and support manufacturers to safely place their products on the UK market.
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