Glossary · EU medical devices: MDR
Rule 11: software classification (MDR)
Also known as: Rule 11, MDR Rule 11, Software classification rule
Under Rule 11 of Annex VIII of the EU Medical Device Regulation (EU) 2017/745, software intended to provide information used to take decisions with diagnosis or therapeutic purposes is class IIa, rising to class IIb or III depending on the possible impact of those decisions, and software intended to monitor physiological processes is class IIa or IIb. All other software is class I.
- EU
- MDR
In one sentence
MDR Rule 11 classifies software: decision support is IIa, IIb or III by impact; monitoring is IIa or IIb; all other software is class I.
Example
An app that analyzes skin photos and suggests whether a lesion may be malignant informs diagnostic decisions whose errors could lead to irreversible deterioration of health, so the manufacturer documents it as class III under Rule 11.
How it applies
- Decision support: Class IIa by default; class IIb if the decisions may cause a serious deterioration of health or a surgical intervention; class III if they may cause death or an irreversible deterioration of health.
- Monitoring: Software to monitor physiological processes is class IIa; class IIb if it monitors vital physiological parameters where variations could result in immediate danger to the patient.
- Everything else: All other software is class I. In practice few medical device software products end up in class I, because most provide information for diagnosis or therapy.
- Guidance: MDCG 2019-11 explains qualification and classification of software under MDR and IVDR, with decision steps and examples.
- AI: Class IIa and higher means notified body involvement, so AI software classified under Rule 11 is usually a high-risk AI system under the AI Act; see AI in medical devices.
- Technical documentation: Record which branch of Rule 11 applies, the clinical decisions the output informs and the worst credible consequence of a wrong output; link it to the risk analysis under ISO 14971.
Rule 11 vs. IEC 62304 safety classes
Rule 11 sets the regulatory class of the device and so the conformity assessment route. The IEC 62304 software safety classes A, B and C set the rigor of the software lifecycle processes, based on the harm a software failure could contribute to. A class IIb device can contain class A, B or C software items; the two classifications are made separately and for different purposes.