Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.
Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.
The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.
It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.
You must understand the importance of protecting your trade secrets or the development of your medical software was useless!
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).