Knowledge Center

View all our technical, regulatory and normative information including guides, webinars, 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 (...)

Learn more
Newsletters

In vitro diagnostic software: Novelties introduced by Regulation (EU) 2017/746

Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

Learn more
Newsletters

Regulation on medical devices: the news of the month of June decrypted

This special July edition is dedicated to two publications from June and the EPSCO (Employment, Social Policy, Health and (...)

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 (...)

Learn more
Newsletters

Summary of Safety and Clinical Performance (SSCP): 5 Challenges to be met

The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

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 (...)

Learn more
Newsletters

UKCA marking: Key steps to consider

The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom (...)

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 (...)

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 (...)

Learn more
Guides

Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with (...)

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 (...)

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 (...)

Learn more
Newsletters

Transition to European Medical Device Regulation: Feedback and Challenges to be met

Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common (...)

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 (...)

Learn more
Guides

Changes to medical device and/or quality management system: when and how to submit a request?

The purpose of the guide, prepared by GMED, is to clarify when and how to submit a change application (...)

Learn more