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25 March 2024

LNE-GMED UK: new opportunities to reach the UK market

Ensuring manufacturers access to the UK market

LNE-GMED UK confirms its ambition to secure access for manufacturers to the UK market. Thanks to its Approved Body, status, our subsidiary has been granting UKCA Marking to measuring instruments, non-automatic weighing instruments (NAWI), outdoor equipment complying with the Noise Directive, and construction products since late 2022.

Simultaneously, LNE-GMED UK has been working towards recognition for the certification of medical devices. This effort was successful, with its accreditation by UKAS in late 2023 under the ISO/IEC 17021-1:2015 norm for quality management system certification activities according to the ISO 13485:2016 norm in the field of medical devices and healthcare, followed by its designation by the MHRA (Healthcare Products Regulatory Agency) in early 2024 under the UK Medical Devices Regulations, to issue the UKCA marking.

UKCA marking is mandatory for all new non-CE-marked medical devices, and for all CE-marked devices incorporating significant innovations. It is also a valuable steppingstone towards CE marking.

LNE-GMED UK also issues UKCA certificates for measuring instruments and NAWIs, based on test and audit reports submitted by the German organism PTB (Physikalisch-Technische Bundesanstalt), with which an agreement has been signed.

By expanding its scope, LNE-GMED UK ensures access to safe, high-performance devices in the UK, and supports any certification projects for its market as part of its accreditations.

La portée de la désignation de LNE-GMED UK est disponible sur le site GOV.UK website

Further information

Visit our LNE-GMED UK subsidiary page