Medical Device Classification: The Software Special
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes. Read more
Tag: Notified Body
EU MDR Factsheet for Manufacturers of Medical Devices
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going. Read more
Transition Period of the EU MDR: What Dates Manufacturers Need to Know
The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period. Read more
CJEU Top Court Cases on Medical Devices
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU). Read more
