Knowledge Center

The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the (...)

The LNE group is expanding its certification activities in the UK by setting up a new subsidiary: LNE-GMED UK. The (...)

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

The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic operators (...)

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-24 guide. This document is intended to help manufacturers (...)

This new digital edition will bring together on a TV studio our speakers who will address several topics including the (...)

The modules: “Unique Device Identification (UDI)” and “Notified Bodies & Certificates” are now available in EUDAMED. Economic operators and notified (...)

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

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 (...)