News
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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 (...)
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, (...)
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 (...)
Best wishes 2021
It is a particular and unprecedented year which has just ended…The mobilization and adaptability of all have made it possible (...)
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 (...)
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: (...)
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 (...)
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 (...)
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 (...)
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 (...)
MDCG Position paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)
European Commission updated FAQs on Unique Device Identification (UDI)
The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)
Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure
The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)
GMED designated under Regulation (EU) 2017/745 on medical devices
GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency (...)