News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

We invite you to take a minute of your time to share your insights on the challenges you would like (...)

The European Commission published a flowchart allowing the manufacturers to determine whether their devices can benefit from the new transitional (...)

“RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of (...)

Have a look at our video to learn more about the value add and benefits our trainings can provide for (...)

Against the recent backdrop of regulatory updates and information for the UKCA marking, LNE-GMED UK has produced a short summary (...)

On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional (...)

The European Commission published a new EUDAMED user guide about the registration of certificates. The purpose of this user guide (...)

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

On May 8, 2023, the European Commission has published its guidance on the content and structure of the summary of (...)

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)