News

Clear search
News

Guidance MDCG 2022-15 on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

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

Learn more
News

European Commission Newsletter on Medical Devices | September 2022

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

Learn more
News

Ava Sainter, IVD Product Reviewer, LNE-GMED UK

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

Learn more
News

Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

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

Learn more
News

New sterilization methods in the GMED’s designation scope under Regulation (EU) 2017/745

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

Learn more
News

Emma Raines, Certification Project Manager, LNE-GMED UK

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

Learn more
News

MDCG 2022-12: Harmonization of administrative practices and alternative technical solutions prior to full functionality of Eudamed under Regulation (EU) 2017/746

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

Learn more
News

Current position of LNE-GMED UK after first review of the consultation on the future regulation of medical devices in the United Kingdom

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

Learn more
News

Implementing Regulation (EU) 2022/1107 laying down common specifications for Class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746

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

Learn more
News

Implementing Regulations (EU) 2022/944 and (EU) 2022/945 laying down detailed rules for the implementation of Regulation (EU) 2017/746 regarding EU Reference Laboratories

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

Learn more
News

MDCG 2022-10: Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

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

Learn more
News

MDCG 2022-9: Summary of Safety and Performance template under Regulation (EU) 2017/746

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

Learn more
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