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...
Historic deal reached on World’s first AI Regulations – The Artificial Intelligence Act!
The Council presidency and negotiators from the European Parliament have achieved a preliminary accord on the proposal for harmonized regulations gov...
EU survey alert: Share your thoughts on medical device regulations (MDR/IVDR)!
EC survey for MD and IVD manufacturers and AR on the status of the MDR/IVDR implementation! This survey is being endorsed by the European Commission (...
Medtech Europe position paper on the future of Europe’s Medical Technology Regulations!
MedTech Europe is outlining the obstacles that medical technologies encounter within the European regulatory framework. According to the latest inform...
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...
Revision of MedDO and IVDO
New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro di...
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...
Advantages of conducting business in the UK. Possible under the MDR?
There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medi...
Flowchart for determining eligibility under the extended MDR transitional period for Devices
The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional per...
