The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated two new UK accredited bodies, providing increased powers 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 seven existing UK accredited bodies, increasing medical device certification capacity in the UK.
LNE-GMED UK is 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 as Assessed and Certified Software and AI. Medical Devices (AI/SAMD).
After two of the existing UK accredited bodies expanded their scope, UL International UK is now designated to assess and certify general medical devices (in addition to in-vitro devices) and TÜV SÜD is now designated to assess and certify active implantables (general medical devices in addition).
In addition to very low risk devices, manufacturers must apply for UKCA certification to a UK authorized body. Products can only be placed on the market in England, Wales and Scotland after they have achieved certification.
Our mission is to ensure patients have access to the high-quality, safe and effective products they need to protect their health.
Authorized companies play an important role in the supply of medical devices and increasing capacity in this area is a key priority for us, helping manufacturers bring their products to the UK.”
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access
Before appointing an authorized agency, the MHRA conducts a detailed assessment process to ensure that the agency:
- Able to undertake assessment activities that are stable and objective and consistent with objectives
- Have an appropriate quality management system
- Have the ability and competence to assess and that the processes they use meet relevant regulatory requirements.
Following successful designation, the MHRA regularly audits and monitors the activities of UK authorized bodies by witnessing some of their audits of manufacturers.