The UK Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the country’s capacity to certify the safety and performance of medical devices.
Two new UK approved bodies, LNE-GMED UK and Scarlet NB UK, have been designated, joining the existing seven to facilitate the certification process for healthcare professionals and the public.
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LNE-GMED UK is now authorised to evaluate and certify general medical devices under Part II of the UK Medical Devices Regulations 2002.
Scarlet NB UK has a specific remit for analysing and certifying software and artificial intelligence as a medical device (AI/SaMD).
This development follows the extension of the scope for two pre-existing UK approved bodies.
UL International UK was previously granted the ability to certify general medical devices in addition to in-vitro devices.
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By GlobalDataWhile TÜV SÜD’s designation has been expanded to include active implantable medical devices, building on their existing general medical device certification capabilities.
Manufacturers seeking to market their products in England, Wales, and Scotland are required to obtain UKCA certification from a UK-approved body for all but the lowest-risk devices.
The MHRA ensures these bodies are capable of conducting impartial and objective conformity assessments through a rigorous evaluation process.
This includes verifying the stability of the organisation, the effectiveness of its quality management system, and its competence and capacity to meet regulatory requirements.
Once designated, the MHRA continues to oversee the activities of UK approved bodies.
This oversight includes routine audits and direct observation of some audits conducted on manufacturers, ensuring ongoing compliance with regulatory standards.
MHRA Healthcare Quality and Access interim executive director Julian Beach 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.”
