News

Clear search
News

MDCG 2022-8: Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular (...)

Learn more
News

MDCG 2022-7: Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-7 questions and answers on the Unique Device Identification (...)

Learn more
News

List of harmonized standards under Regulation (UE) 2017/745

For your information the European Commission has just published the implementing decision (UE) 2022/757 amending the list of harmonized European (...)

Learn more
News

List of harmonized standards under Regulation (EU) 2017/746

The European Commission has just published the implementing decision (EU) 2022/729 amending the list of harmonized European standards under Regulation (...)

Learn more
News

Guidance MDCG 2022-6 on significant changes regarding the transitional provision under Article 110(3) of the IVDR

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-6 which aim to provide clarification on the (...)

Learn more
News

Guidance MDCG 2022-5 on borderline between medical devices and medicinal products under Regulation (EU) 2017/745

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation between (...)

Learn more
News

Newsletter on Medical Devices | European Commission – April 2022

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

Learn more
News

Revision of Guide MDCG 2019-9 Rev.1 on the summary of safety and clinical performance

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

Learn more
News

GMED has certified its first in vitro diagnostic medical devices under Regulation (EU) 2017/746

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

Learn more
News

Amendment A11 of NF EN ISO 14971:2019 Standard

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

Learn more
News

MDCG Guidance 2022-2 on general principles of clinical evidence for In Vitro Diagnostic Medical Devices

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

Learn more
News

The progressive implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices is officially adopted

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

Learn more
News

GMED recognized as a Notified Body partner in the new TCP III mutual recognition program (Taiwan)

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

Learn more
News

Teresa Perry, Quality & Accreditation Director at LNE-GMED UK

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

Learn more
News

MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

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

Learn more
News

New harmonized European standards under Regulation (EU) 2017/746

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

Learn more
News

New harmonised European standards under Regulation (EU) 2017/745

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

Learn more
News

MDCG 2021-28: Model notification form for substantial modification of clinical investigation under Medical Device Regulation (EU) 2017/745

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

Learn more
News

Instructions for Electronic use of medical devices: Publication of the Implementing Regulation (EU) 2021/2226 in the OJEU

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

Learn more
News

Best wishes 2022

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

Learn more
News

EUDAMED: The Official Journal of the European Union has published the commission implementing regulation (EU) 2021/2078

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

Learn more
News

Creation of LNE-GMED UK subsidiary: LNE group increases its international presence

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

Learn more
News

The European Commission proposes a gradual implementation of the European Regulation on in vitro diagnostic medical devices

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

Learn more
News

MDCG 2021-24 Medical Device Classification Guidance

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

Learn more
News

On November 16th, GMED is organizing its IVDMD Forum: Implementation of Regulation (EU) 2017/746

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

Learn more
News

EUDAMED: New modules available

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

Learn more
News

Expert panels for IVDMDs

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

Learn more
News

MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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

Learn more
News

Publication of the MDCG 2021-22 Guidance

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

Learn more
News

First lists of harmonized European standards under the European Regulations on MDs and IVDs

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

Learn more