News

From Paris to Washington D.C., via London and Hong Kong, all our teams would like to thank you for the (...)

The MDCG has just published a form for manufacturers to report interruptions or discontinuation of the supply of certain IVDs (...)

The European Commission has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (...)

The European Commission has launched a public consultation and call for evidence on the European Regulation on medical devices and (...)

In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and (...)

The European Commission has published a Q&A on the practical aspects related to the implementation of the obligations, laid down (...)

The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the (...)

GMED will be attending MedFIT from December 3 to 4 at Lille and from December 11 to 12 for online (...)

A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis to (...)

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

The guidance MDCG 2021-25 on the application of the MDR requirements to ‘legacy devices’ has been updated in order to (...)

On October 8, 2024, the MDCG published a guidance that clarifies what products fall in the scope of Regulation (UE) 2017/746 (...)

The Commission Implementing Decisions (EU) 2024/2631 and (EU) 2024/2625 have been published in the Official Journal of the European Union (...)

We are delighted to announce the launch of our new format, GMED Highlights. Every month, GMED Highlights brings you a (...)

GMED, a subsidiary of the LNE group, is expanding its certification business with the creation of GMED Asia, based in (...)

Based in London, LNE-GMED-UK has been officially designated as a critical location for both GMED’s COFRAC accreditation and MDSAP Auditing (...)

An updated version (version 009) of the MDSAP Audit Approach is now available. The following changes have been made: Update/removal (...)

On Friday July 12th, 2024, Regulation (UE) 2024/1689 was published in the Official Journal of the European Union (OJEU). Better (...)

This document aims to provide guidance relating to the medical devices sector standards, in support of the requirements laid down (...)

The Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) has been published in the Official Journal (...)

Published on June 25, 2024, the MDCG 2024-10 guidance on the clinical evaluation of ‘orphan devices’ clarifies the criteria for (...)

GMED is pleased to announce the arrival of Romuald Gorjup as Certification Director at the French entity GMED SAS. Romuald (...)

We are pleased to announce that Tom Patten has joined the GMED Group as IVDR/IVD International Manager. Tom also brings (...)

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

LNE, GMED’s parent company, and INRIA have just signed a framework agreement defining their roadmap, with the aim of setting (...)

LNE-GMED UK, as an Approved Body, collaborates with Team-AB and the MHRA to streamline the pathway for medical devices in (...)

  GMED will be exhibiting at MedtecLIVE from June 18 to 20 in Stuttgart, Germany. MedtecLIVE, Europe’s leading trade fair (...)

From September 17-19 (Long Beach, California), we will be attending RAPS Convergence, a major event for regulatory professionals in the (...)

According to Regulation (EU) 2023/607, you have to submit an application for certification to a notified body before the May (...)

Teresa Perry has held the position of Branch Director and Head of Approved Body at LNE-GMED UK since May 1st, (...)