The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They 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).
In addition, 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.
“Our mission is to ensure that patients have access to the high-quality, safe, and effective products they need to protect their health,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access. “Approved Bodies play a critical role in the supply of medical devices, and expanding capacity in this area is a key priority for us.”
Before appointing an Approved Body, the MHRA conducts an assessment process to ensure organizations:
- 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 that the processes they use meet the relevant regulatory requirements
After successful designation, the MHRA monitors UK approved bodies’ activities by performing regular audits and by witnessing some of their audits of manufacturers.
Organizations that would like to become an approved body can contact info@mhra.gov.uk.
Learn more about current UK Approved Bodies.
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