MHRA designates LNE-GMED and Scarlet become Approved Bodies

LNE-GMED and Scarlet have been added been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA).

This further expands the list of the UK approved bodies for medical devices after the addition of Intertek, TUV SUD and TUV Rheinland to the list last year. They joined BSI, Dekra, SGS and UL International.

GMED has been designed an approved body for active implantable medical devices (UK MDR 2002 – Part. III) and in vitro diagnostic medical devices (UK MDR 2002 – Part. IV) will be added shortly to the designation scope after the extension of the ISO 17021-1 accreditation by the United Kingdom Accreditation Service (UKAS).

Scarlet has been formally accredited for UK MDR 2002 for medical devices incorporating, using or are controlled by software.

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."