News

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, (...)

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 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 (...)

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