LNE-GMED UK full designation scope under UK Medical Devices Regulations 2002

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has now completed its designation scope under UK Medical Devices Regulations 2002, having been consecutively designated for medical devices, in vitro diagnostic medical devices and active implantable medical devices by the Medicines and Healthcare Products Regulatory Agency (MHRA). 

Hence, following successful accreditation against ISO/IEC 17021-1 (active implantable medical devices (AIMD) technical area), by UKAS, LNE-GMED UK now broadens its services to AIMDs and is mobilizing its teams to offer manufacturers certification services in this field.

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), some in partnership with GMED and GMED North America services.

With its accreditations and designations, 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 is available on the GOV.UK website