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.
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.