Overig

Explanation flowchart Medical apps is certification required

Auteur(s)
Anton Ekker en Barbara van Rest
Soort publicatie
Overig
Uitgever(s)
Nictiz
Datum
16/12/2013
Bestand

​Consumers and healthcare providers increasingly use medical apps. Some medical apps are considered as medical devices. CE marking ensures that medical devices comply with the European requirements. We have made an infographic that shows whether a medial app needs CE marking. After going through the flowchart you will also know which risk categories the app comes under and what form of certification is required. This document contains a brief explanation of the flowchart. This explanation belongs to the flowchart in the infographic ‘Medical apps, is certification required?‘.