News
UKCA, MDSAP, UKAS and now COFRAC accredited services all managed locally from the UK
Based in London, LNE-GMED-UK has been officially designated as a critical location for both GMED’s COFRAC accreditation and MDSAP Auditing (...)
Update of the MDSAP AU P0002 document – Audit Approach
An updated version (version 009) of the MDSAP Audit Approach is now available. The following changes have been made: Update/removal (...)
AI Act: publication in the OJEU
On Friday July 12th, 2024, Regulation (UE) 2024/1689 was published in the Official Journal of the European Union (OJEU). Better (...)
1st revision of the MDCG 2021-5 guidance on standardisation for medical devices
This document aims to provide guidance relating to the medical devices sector standards, in support of the requirements laid down (...)
Regulation (EU) 2024/1860: Extension of the IVDR transitional period and other provisions
The Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) has been published in the Official Journal (...)
MDCG 2024-10 guidance on clinical evaluation of orphan medical devices
Published on June 25, 2024, the MDCG 2024-10 guidance on the clinical evaluation of ‘orphan devices’ clarifies the criteria for (...)
GMED leadership evolves
GMED is pleased to announce the arrival of Romuald Gorjup as Certification Director at the French entity GMED SAS. Romuald (...)
Tom Patten, IVD International Manager for the GMED Group
We are pleased to announce that Tom Patten has joined the GMED Group as IVDR/IVD International Manager. Tom also brings (...)
European Commission Newsletter on medical devices | May 2024
This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)
Artificial intelligence, the heart of our stakes
LNE, GMED’s parent company, and INRIA have just signed a framework agreement defining their roadmap, with the aim of setting (...)
The MHRA announced a framework for international recognition of medical devices
LNE-GMED UK, as an Approved Body, collaborates with Team-AB and the MHRA to streamline the pathway for medical devices in (...)
GMED at MedtecLIVE
GMED will be exhibiting at MedtecLIVE from June 18 to 20 in Stuttgart, Germany. MedtecLIVE, Europe’s leading trade fair (...)
GMED North America at RAPS Convergence
From September 17-19 (Long Beach, California), we will be attending RAPS Convergence, a major event for regulatory professionals in the (...)
Do you market class I medical devices under the Directive, which have been reclassified to a higher class under MDR?
According to Regulation (EU) 2023/607, you have to submit an application for certification to a notified body before the May (...)
The leadership of LNE-GMED UK is evolving
Teresa Perry has held the position of Branch Director and Head of Approved Body at LNE-GMED UK since May 1st, (...)
GMED at MedTech Forum 2024
Meet our team at The MedTech Forum in Vienna from May 22 to 24, Europe’s leading healthcare and medical technology (...)
MDCG 2024-4 guidance on safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The recording and reporting to competent authorities of adverse events occurring during performance studies of in vitro diagnostic medical devices (...)
1st revision of the MDCG 2022-9 guidance on the template for the Summary of Safety and Performance characteristics under Regulation (EU) 2017/746
Published by the Medical Device Coordination Group (MDCG), the MDCG 2022-9 guidance proposes a template to follow the Summary of (...)
LNE-GMED UK full designation scope under UK Medical Devices Regulations 2002
LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has now completed its designation scope under UK Medical (...)
LNE-GMED UK designated for in vitro diagnostic medical devices under UK Medical Devices Regulations 2002 – Scope Extension
LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has just been designated as an Approved Body for (...)
GMED at RAPS Euro Convergence 2024
Join us in Berlin from May 6 to 8 for RAPS Euro Convergence 2024, the must-attend event for medical device (...)
LNE-GMED UK accredited for IVDs under ISO/IEC 17021-1:2015 standard
LNE-GMED UK, GMED subsidiary of the LNE group, has extended its accreditation by UKAS under ISO/IEC 17021-1:2015 for quality management (...)
Guidance MDCG 2024-3 on content of the Clinical Investigation Plan for clinical investigations of medical devices
The Medical Device Coordination Group (MDCG) has published the MDCG 2024-3 guide regarding the content of the clinical investigation plan (...)
Update of the list of harmonised standards under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR)
The Commission Implementing Decisions (EU) 2024/815 and (EU) 2024/817 have been published in the Official Journal of the European Union (...)
GMED and LNE at Medi’nov
From April 3 to 4 at the Lyon Convention Center, join the GMED and LNE teams for the latest edition (...)
LNE-GMED UK is one of the founding members of Team-AB, the UK Association for Medical Device Approved Bodies
In the evolving regulatory context in Great Britain, a group of UK Approved Bodies formed “Team-AB” in February 2024. This (...)
GMED at the MedTech Meetup
Meet our team at the 7th edition of the MedTech Meetup, on March 14 in Brussels. Hosted by (...)
Publication of guidance MDCG 2024-1 and ancillary guidances MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, MDCG 2024-1-4
The Medical Device Coordination Group (MDCG) has just published new guidances that describe how to report to competent authorities incidents (...)
LNE-GMED UK designated under UK Medical Devices Regulations 2002
LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has been designated as an Approved Body under the (...)
Publication of tables summarising the language requirements applicable in each Member State
The European Commission has published on its website tables listing all the language requirements mentioned in Regulations (EU) 2017/745 (MDR) (...)