Knowledge Center

The objective of this document is to identify the priority actions to be implemented in order to meet the requirements (...)

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

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

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

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

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

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

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

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

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

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Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)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 (...)