The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies to increase capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public.
LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices within 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 while Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).
The news 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 onto 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 health regulator 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.
