MedTech Europe has released a template to assist In Vitro Diagnostics (IVD) manufacturers in complying with Regulation (EU) 2024/1860. This reg...
Important News for IVD and MD Manufacturers!
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to info...
Commission proposal on extending IVDR transition and expediting EUDAMED adoption!
Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the al...
Overview of language requirements for manufacturers of medical devices
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...