Knowledge Center

The involvement of European Union Reference Laboratories (EURLs) is a new requirement described in Article 100 of Regulation (EU) (...)

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

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

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

On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation (...)

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

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

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

Regulations (EU) 2017/745 & 2017/746 introduce “new” requirements for distributors and importers who carry out activities involving the repackaging, (...)

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

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

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

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

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

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 (...)