Knowledge Center

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 (...)

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

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

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

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

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

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

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

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

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

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

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

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

After obtaining UKAS ISO/IEC 17065:2012 accreditation, LNE-GMED UK (part of LNE Group) was originally appointed by the UK Government (...)

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-4 guidance on MDSW intended to work in combination (...)

The new regulatory deadlines open up new perspectives for marketing your medical devices in Europe, even for the most (...)

The European Commission has published a Q&A on the transitional provisions applicable to products without an intended medical purpose (...)

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

We are pleased to announce the arrival of Andrew Bailey to our subsidiary LNE-GMED UK, in the position of (...)

As part of the GMED Group’s expansion, GMED North America is excited to announce that we have relocated our (...)