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...
Swiss Database on Medical Devices – swissdamed!
Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully...
Important Announcement: CE-Marking Extensions and Medical Devices in the UK
The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...
