LNE-GMED UK designated for in vitro diagnostic medical devices under UK Medical Devices Regulations 2002 – Scope Extension

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has just been designated as an Approved Body for in vitro diagnostic medical devices (IVDs) under the UK Medical Device Regulations 2002 by the Medicines and Healthcare Products Regulatory Agency (MHRA). 

Following successful accreditation against ISO/IEC 17021-1 (IVD technical area), by UKAS, LNE-GMED UK now broadens its services to IVDs (UK MDR 2002 – Part. IV) and is mobilizing its teams to offer manufacturers certification services in this field.

Active implantable medical devices (UK MDR 2002 – Part. III) will be added shortly to the designation scope.

LNE-GMED UK has set up optimized processes to accompany manufacturers in the marketing of their products in the UK. Transfers may also be carried out as part 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 extended 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