Knowledge Center

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of (...)

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

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

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

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

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