News
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 (...)