News

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2022-16 for authorized representatives, manufacturers, and other economic operators. (...)

GMED has extensive experience with a team specialized in assessing medical devices incorporating medicinal substances under Regulation (EU) 2017/745 (analyzing (...)

On 21st October 2022, the Medicines & Healthcare products Regulatory Agency (MHRA) has just informed the industry stakeholders of a (...)

The MDCG (Medical Devices Coordination Group) published the guidance MDCG 2022-15 on the appropriate surveillance to be conducted by Notified Bodies (...)

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

We are pleased to announce that Ava Sainter has joined our LNE-GMED UK subsidiary as an in vitro diagnostic (IVD) (...)

The Borderline and Classification Working Group has just published on the European Commission website the Manual on borderline and classification (...)

GMED (CE 0459) is pleased to inform you about its evolution of scope of its designation as a Notified Body (...)

We are pleased to announce that Emma Raines has joined our subsidiary LNE-GMED UK as Certification Project Manager. With a (...)

The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-12. This guidance is intended to enable Member States (...)

On 26th June 2022, the UK Government outlined the results on the consultation on the future regulation of medical devices (...)

In order to provide appropriate provisions regarding Class D in vitro diagnostic medical devices, the European Commission has adopted the (...)

In order to provide the necessary modalities as mentioned in Article 100 of the Regulation (EU) 2017/746 concerning the EU (...)

This Q&A intends to clarify certain interfaces between both following regulations: the Regulation (EU) No 536/2014 on clinical trials for (...)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary (...)

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

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

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

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

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

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

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 (...)