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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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, (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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Instructions for Electronic use of medical devices: Publication of the Implementing Regulation (EU) 2021/2226 in the OJEU

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

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Best wishes 2022

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

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EUDAMED: The Official Journal of the European Union has published the commission implementing regulation (EU) 2021/2078

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

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Newsletters

Biological evaluation: chemical characterization according to EN ISO 10993-18:2020

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

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News

Creation of LNE-GMED UK subsidiary: LNE group increases its international presence

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

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Guides

Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation (...)

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News

The European Commission proposes a gradual implementation of the European Regulation on in vitro diagnostic medical devices

The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic (...)

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