MDR Annex VIII, Rule 11
Rule 11 moved most medical device software out of Class I. Classification depends on the decisions the software informs and on what happens if the information is wrong.
| Software | Class |
|---|---|
| Provides information used to take decisions with diagnosis or therapeutic purposes | IIa |
| ... where such decisions could cause a serious deterioration of health or a surgical intervention | IIb |
| ... where such decisions could cause death or an irreversible deterioration of health | III |
| Intended to monitor physiological processes | IIa |
| Intended to monitor vital physiological parameters, where variations could result in immediate danger to the patient | IIb |
| All other software | I |
Software that drives or influences the use of a device falls within the same class as that device. MDCG 2019-11 gives qualification and classification guidance with examples.
Software is a medical device when the manufacturer intends it for a medical purpose listed in Article 2(1) MDR - for example diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Software for general wellbeing, administration or simple storage and communication of data is usually not a device.
No. Software that informs diagnostic or therapeutic decisions or monitors physiological processes is at least Class IIa, but other medical device software falls into Class I.
When it provides information used for decisions that could cause death or an irreversible deterioration of a person's state of health.
It can. AI systems that are medical devices, or safety components of them, requiring Notified Body assessment are high-risk AI systems under the AI Act.
All MDR rules.
On representAI.eu.
Software verification and validation.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Check the consolidated text on EUR-Lex and the relevant MDCG guidance for your device. Last reviewed 30 September 2026.