Knowledge Center

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 (...)

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

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

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

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

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

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

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

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

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

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

The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing (...)

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