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Questions & Answers from the European Commission on the European Medical Device Nomenclature (EMDN)

The European Commission has just published a document gathering questions and answers on the EMDN. In accordance with Article 26 (...)

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FAQ on the European Medical Device Nomenclature (EMDN)

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-12 FAQ on medical devices and in vitro diagnostic (...)

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English version of the European Medical Device Nomenclature (EMDN)

A public consultation was organized by the European Commission on the European Nomenclature of MDs and IVD MDs (EMDN) within (...)

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MDCG 2021-08 Guidance on Clinical Investigation Application and Notification Documents

Medical Devices Coordination Group (MDCG) has published a guidance on clinical investigation Application and Notification documents. The sponsor of a (...)

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European Commission factsheet for manufacturers of implantable medical devices

Are you a manufacturer of implantable medical devices? Everything you need to know about the implant card and the information (...)

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Newsletters

Introduction to the Regulation (EU) 2017/746

The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)

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Launch of the Unique Device Identification (UDI) Helpdesk

On May 17, 2021, the European Commission launched a new helpdesk to assist economic operators in the implementing the obligations (...)

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Harmonized European Standards under the European Regulations on MD and IVD MD

On May 12, 2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) formally informed (...)

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MDCG 2021-5 Guidance on standardisation for medical devices

The Medical Devices Coordination Group (MDCG) has just published guidance on standardisation for medical devices. The aim of this document (...)

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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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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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