After a favorable MHRA audit, LNE-GMED UK, subsidiary of the GMED Group, is now in the final stages of obtaining its designation under the UK Medical Devices Regulations, SI 2002 No 618, as amended (UK MDR). LNE-GMED UK will then be recognized as a UK Approved Body (UKAB) for medical devices (MDs) and in vitro diagnostic medical devices (IVDs).
GMED group is extending its certification activities in the UK via its subsidiary, LNE-GMED UK, which, thanks to its status as a certification body, will guarantee access to the UK market. It will also be able to support customers and manufacturers in pursuing CE marking, having their QMS certified, and benefiting from the MDSAP program and all the other services offered by the GMED group.
Despite the regulatory environment evolving sometimes suddenly, GMED Group wants to reassure its customers and all manufacturers of its clear and predictable roadmap and goals: provide manufacturers of MDs and IVDs with the largest scope of designation and access to the international market.