The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the ...
Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR)
This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment o...
Important Updates on EUDAMED and Economic Operator Responsibilities!
The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibiliti...
Manual on borderline and classification for medical devices under MDR & IVDR!
A new version was just published. This manual serves as a valuable resource for understanding classification rules and define whether your product qu...
Q & A – new Manufacturer Incident Report (MIR) Form
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website....
New documents published by the Commission!
– The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) ...
New Guidance published by the Commission!
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereafter called the Medical DevicesRegulations) have...
New Vigilance documents published on the European Commission website!
The following important vigilance documents have been published on the European website: Additional guidance on the MEDDEV 2.12/1 rev.8 Device speci...
European Commission offers Guidance on UDIs!
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device i...
