The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare professionals and the public.
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK.
TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. TÜV Rheinland UK has also been designated to assess and certify general medical devices as well as in-vitro diagnostics in accordance with Part IV.
With the exception of 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.
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."
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, that they have an appropriate quality management system, 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.
Date: 13 September