Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.
The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR.