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GMED NA at RAPS
Convergence 2024

Join us in Long Beach, California from September 17 to 19 for RAPS Convergence 2024, the premier event for (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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LNE-GMED UK Guides

How to change your Approved Body to LNE-GMED UK in 8 steps

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

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News

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 (...)

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News

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 (...)

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Newsletters

Periodic safety update reports for devices: requirements and feedback

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

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News

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 (...)

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News

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 (...)

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News

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. (...)

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News

GMED at the MedTech Meetup

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

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

1st revision of the guidance MDCG 2019-07 on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) regarding the ‘person responsible for regulatory compliance’ (PRRC)

The Medical Device Coordination Group (MDCG) has made several additions throughout the MDCG 2019-7 guidance, including on the qualifications, (...)

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News

Happy New Year 2024

All the best for 2024! In this time of regulatory change, all of our teams would like to thank (...)

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News

MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-6 guidance that is applicable to products without an (...)

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News

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-5 guidance that provides elements useful for the qualification (...)

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News

LNE-GMED UK accredited under ISO/IEC 17021-1:2015 standard

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

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News

Designation of European Union Reference Laboratories

The Official Journal of the European Union has published Implementing Regulation (EU) 2023/2713 designating European Union Reference Laboratories (EURLs) (...)

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GMED Guides

Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with (...)

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News

Publication of Commission Regulation (EU) 2023/2482 of November 13, 2023

Commission Regulation (EU) 2023/2482 of November 13, 2023, amending Regulation (EC) No 1907/2006 (REACH) of the European Parliament and (...)

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Newsletters

Combined audits MDD/AIMDD and MDR : requirements and impact on the quality management system

The date after which “legacy devices” can no longer be placed on the market or put into service pursuant (...)

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News

LNE-GMED UK: successful final step before designation under the UK Medical Devices Regulations

After a favorable MHRA audit, LNE-GMED UK, subsidiary of the GMED Group, is now in the final stages of (...)

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