News

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, (...)

Meet our team at The MedTech Forum in Vienna from May 22 to 24, Europe’s leading healthcare and medical technology (...)

The recording and reporting to competent authorities of adverse events occurring during performance studies of in vitro diagnostic medical devices (...)

Published by the Medical Device Coordination Group (MDCG), the MDCG 2022-9 guidance proposes a template to follow the Summary of (...)

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has now completed its designation scope under UK Medical (...)

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has just been designated as an Approved Body for (...)

Join us in Berlin from May 6 to 8 for RAPS Euro Convergence 2024, the must-attend event for medical device (...)

Within the constantly changing regulatory framework, more and more companies are requesting the transfer of their certificates to an Approved (...)

LNE-GMED UK, GMED subsidiary of the LNE group, has extended its accreditation by UKAS under ISO/IEC 17021-1:2015 for quality management (...)

The Medical Device Coordination Group (MDCG) has published the MDCG 2024-3 guide regarding the content of the clinical investigation plan (...)

The Commission Implementing Decisions (EU) 2024/815 and (EU) 2024/817 have been published in the Official Journal of the European Union (...)

From April 3 to 4 at the Lyon Convention Center, join the GMED and LNE teams for the latest edition (...)

In the evolving regulatory context in Great Britain, a group of UK Approved Bodies formed “Team-AB” in February 2024. This (...)

    Meet our team at the 7th edition of the MedTech Meetup, on March 14 in Brussels. Hosted by (...)

The Medical Device Coordination Group (MDCG) has just published new guidances that describe how to report to competent authorities incidents (...)

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has been designated as an Approved Body under the (...)

The European Commission has published on its website tables listing all the language requirements mentioned in Regulations (EU) 2017/745 (MDR) (...)