Knowledge Center

The European Commission’s website indicates that the expert panels for in vitro diagnostic medical devices is now accepting submissions from (...)

The Medical Device Coordination Group has published the MDCG 2021-23 guidance. This guidance is intended to provide assistance to notified (...)

The Medical Device Coordination Group has just published the MDCG 2021-22 guide regarding the clarification on “the 1st certification for (...)

The European Commission has published in the Official Journal of the European Union, the list of the first harmonized European (...)

The Medical Device Coordination Group has just published the MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic (...)

GMED (CE 0459) has just been designated as a Notified Body under Regulation (EU) 2017/746 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) (...)

The Medical Devices Coordination Group (MDCG) has just published an explanatory note regarding code assignment under Regulation (EU) 2017/746. The (...)

The Medical Device Coordination Group has just published guidance note MDCG 2021-19 on integrating UDI -within an organization’s quality management (...)

The Medical Device Coordination Group (MDCG) has just revised the MDCG 2021-13 Guidance published last June by adding a 9th (...)

The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. (...)

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 (...)