Knowledge Center

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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