LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK.
LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).
This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify active implantables (in addition to general medical devices).
Apart from the very lowest risk devices, manufacturers must apply to a UK approved body for UKCA certification. Products can only be placed on the market in England, Wales and Scotland after they have achieved certification.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Our mission is to ensure that patients have access to the high-quality, 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 in this area is a key priority for us, to support manufacturers to bring their products to the UK.
Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organisations:
- are stable and able to undertake impartial and objective conformity assessment activities
- have an appropriate quality management system
- have the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements.
After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.
For any organisations wanting to become an approved body, please contact [email protected].
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Notes to editors
- An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care (DHSC).
- For media enquiries, please contact the [email protected], or call on 020 3080 7651.