Knowledge Center

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

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

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

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Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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