LNE-GMED UK designated under UK Medical Devices Regulations 2002

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has been designated as an Approved Body under the UK MDR 2002 by the Medicines and Healthcare Products Regulatory Agency (MHRA).

An Approved Body for non-medical legislations since October 2022, LNE-GMED UK broadens its services to medical devices (UK MDR 2002 – Part. II) and is mobilizing its teams to offer manufacturers certification services in this field.

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).

To accompany manufacturers in bringing their products to the UK market, LNE-GMED UK has set up optimised certification processes. Transfers may also be carried out within the framework of regulatory certifications (CE and UKCA markings) and voluntary certifications (ISO 13485:2016, MDSAP program).

By extending its scope, LNE-GMED UK is ensuring access to safe, high-performance devices in the UK. This approach confirms the ambition of GMED and its subsidiaries to serve the healthcare industry on a large scale, supporting innovation while enhancing patient safety.

The scope of LNE-GMED UK’s designation will be available shortly on the GOV.UK website: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices