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Factsheet of the European Commission of Class I medical devices under Regulation (EU) 2017/745

Are you a manufacturer of Class 1 medical devices? What you need to know about Regulation (EU) 2017/ 745 is (...)

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Publication of a new revision (rev. 4) of the MDCG 2018-1 Guidance on basic UDI-DI and changes related to UDI-DI

In the MDCG 2018-1 Rev. 4 Guidance, the definition of the basic UDI-DI has been revised by deleting the concept (...)

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Certification process for SARS-CoV-2 self-tests

In the context of the health crisis, the French and European authorities have authorized a derogation for the placing on (...)

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Newsletters

Clinical evaluation in the era of Regulation (EU) 2017/745

In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

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MDCG Infographic “Is your software a medical device ?”

The European Commission has just published the infographic titled “Is your software a medical device?” This infographic outlines the main (...)

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Publication of a European Commission guide on the management of Legacy Devices in EUDAMED

The European Commission has published a guide on the management of Legacy Devices in EUDAMED. Legacy devices are defined as (...)

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MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

The European Commission has just published the Guidance MDCG 2021-1. This document intends to describe harmonized administrative practices and alternative (...)

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GMED has certified its first medical devices under Regulation (EU) 2017/745

GMED is pleased to announce that its team has issued its first certificates under the European Medical Device Regulation. Since (...)

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Newsletters

MDSAP Program: Principles, Implementation and Advantages

The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)

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Appointment of expert panels by the European Commission

The European Commission has just appointed expert panels in the field of medical devices and in vitro diagnostic medical devices (...)

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GMED Newsletter : Qualification and Classification of Medical Device Software under Regulation (EU) 2017/745

Last October, when our website was launched, you discovered our new Knowledge Center, centralizing our news, guides and webinars. Today, (...)

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Newsletters

Qualification and Classification of Medical Device Software under Regulation (EU) 2017/745

Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient (...)

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Publication of a Team-NB position paper on changes affecting the device component of a drug device combination under Article 117 of the Medical Device Regulation (EU) 2017/745

Team NB has published on its website a position paper about substantial changes impacting the device component of a drug (...)

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Best wishes 2021

It is a particular and unprecedented year which has just ended…The mobilization and adaptability of all have made it possible (...)

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MDCG summary document on UDI assignment for Spectacle lenses & Ready readers

The Medical Device Coordination Group (MDCG) has just published a summary document on the UDI assignment (Unique Device Identifier) for (...)

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EUDAMED: Launch of the economic actors’ registration module

The European Commission has recently rolled out the first EUDAMED module called “Actor registration module” and intended for economic operators: (...)

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Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

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European Commission publication on EUDAMED and the module on economic actors’ registration

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

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The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

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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 and (...)

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News

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)

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MDCG Position paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)

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European Commission updated FAQs on Unique Device Identification (UDI)

The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)

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Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure

The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)

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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 the (...)

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GMED designated under Regulation (EU) 2017/745 on medical devices

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency (...)

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Guides

Application request for CE marking certification – Regulation (EU) 2017/745

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

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Guides

Codes assignment referred to in the implementing Regulation 2017/2185 in the context of a request for certification according to the Regulation (EU) 2017/745

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under (...)

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Guides

How to change your Notified Body to GMED in 8 steps

Within the constantly changing regulatory framework and in view of uncertainties regarding the future of certain notified bodies, more and (...)

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Webinars

Stepping into an MDSAP audit

The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch (...)

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