News

This newsletter from the European Commission aims to provide highlights and updates from the medical devices sector. In this new (...)

The Medical Device Coordination Group (MDCG) has just published the updated Guide MDCG 2019-9 Rev.1. This March 2022 revision provides (...)

GMED is pleased to announce that its team has issued its first certificates under the European In Vitro Diagnostic Medical (...)

The amended standard NF EN ISO 14971 has been published in its December 2021 version. Added Annexes ZA and ZB (...)

The MDCG (Medical Device Coordination Group) has recently published the MDCG 2022-2 Guidance which outlines the general principles of clinical (...)

Regulation (EU) 2022/112 of the European Parliament and of the Council has been published in the Official Journal of the (...)

GMED is one of the 6 Notified Bodies to have been recognized as a European Notified Body partner in the (...)

David Francis, General Manager of LNE-GMED UK, a subsidiary of the LNE Group and a future UK certification body, is (...)

The Medical Devices Coordination Group (MDCG) has published the notice MDCG 2022-1 for manufacturers of in vitro diagnostic medical devices (...)

The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/15 which amends (...)

The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/6 which amends (...)

The sponsor of a clinical investigation is required to notify the Member States in which a clinical investigation is or (...)

On December 15, 2021, the European Commission published in the Official Journal the Implementing Regulation (EU) 2021/2226 on rules for (...)

GMED wishes everyone a happy new year 2022! Thank you to our customers for their trust, our partners for their (...)

On November 29th, 2021, the European Commission published in the Official Journal the commission implementing regulation (EU) 2021/2078 laying down (...)

The LNE group is expanding its certification activities in the UK by setting up a new subsidiary: LNE-GMED UK. The (...)

The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic operators (...)

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-24 guide. This document is intended to help manufacturers (...)

This new digital edition will bring together on a TV studio our speakers who will address several topics including the (...)

The modules: “Unique Device Identification (UDI)” and “Notified Bodies & Certificates” are now available in EUDAMED. Economic operators and notified (...)

The European Commission’s website indicates that the expert panels for in vitro diagnostic medical devices is now accepting submissions from (...)

The Medical Device Coordination Group has published the MDCG 2021-23 guidance. This guidance is intended to provide assistance to notified (...)

The Medical Device Coordination Group has just published the MDCG 2021-22 guide regarding the clarification on “the 1st certification for (...)

The European Commission has published in the Official Journal of the European Union, the list of the first harmonized European (...)

The Medical Device Coordination Group has just published the MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic (...)

GMED (CE 0459) has just been designated as a Notified Body under Regulation (EU) 2017/746 by the French National Agency (...)

The Medical Devices Coordination Group (MDCG) has just published an explanatory note regarding code assignment under Regulation (EU) 2017/746. The (...)

The Medical Device Coordination Group has just published guidance note MDCG 2021-19 on integrating UDI -within an organization’s quality management (...)

The Medical Device Coordination Group (MDCG) has just revised the MDCG 2021-13 Guidance published last June by adding a 9th (...)

The objective of this document is to identify the priority actions to be implemented in order to meet the requirements (...)