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!
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.