Medical Device Risk Classes: IEC_62304
Medical device regulatory classification rules, risk levels, and required regulatory pathways. Covers four frameworks: FDA 21 CFR Part 860 (Class I / I_non-exempt / II / II_De_Novo / III / III_HDE / III_PDP with 510(k)/De_Novo/PMA/HDE pathways), EU MDR 2017/745 (Class I variants: non-sterile_non-measuring, sterile, measuring, reusable_surgical; Class IIa, IIb, III; Notified Body requirements and PSUR/PMCF obligations), ISO 14971:2019 risk management severity scale (Severity_1_Negligible through Severity_5_Catastrophic with probability/risk matrix guidance), and IEC 62304:2006+AMD1:2015 medical device software safety classes (A: no harm, B: non-serious injury, C: death or serious injury) with SDLC documentation requirements. Each record includes device examples, regulatory pathway, premarket requirements, postmarket obligations, key classification criteria, and cross-reference to applicable IEC 62304 software safety class.
| regulatory framework | device class | class description | device examples | key criteria | notes | postmarket requirement | premarket requirement | regulatory pathway | risk level | software relevance |
|---|---|---|---|---|---|---|---|---|---|---|
| IEC_62304 | Class_A | No injury or damage to health possible | Administrative software, inventory management systems, hospital scheduling software, non-diagnostic patient information displays, barcode readers for logistics, software that generates audit trails only | Software failure cannot contribute to hazardous situation; or risk controls external to software system are sufficient to reduce risk to acceptable level; lowest documentation burden; no software maintenance plan required | Class A has minimal IEC 62304 requirements: only software requirements specification and release documentation; no formal testing per 5.5-5.8; no architecture description required; no configuration management beyond basic | Post-market_monitoring | Software_requirements_and_release_documentation_only | Development_lifecycle_Class_A | No_harm | Applies_to_all_FDA_classes_with_no_software_risk |
| IEC_62304 | Class_B | Non-serious injury possible | Diagnostic imaging display software, physiological monitoring alerting software, infusion pump dose calculation software, hospital EMR ordering systems, radiation therapy planning software (if safeguards exist) | Software failure can contribute to unacceptable risk resulting in non-serious injury; intermediate documentation requirements; full software development lifecycle required; risk management integration required; SOUP evaluation required | Class B requires: software requirements spec, software architectural design, detailed design for SOUP, risk controls traceability, configuration management, software verification, software system testing; NOT required: full code coverage analysis to same depth as Class C | Post-market_monitoring + SOUP_management | Full_SDLC_without_complete_reqs_trace | Development_lifecycle_Class_B | Non-serious_injury | FDA Class I or II devices with software; IEC 62304 applies |
| IEC_62304 | Class_C | Death or serious injury possible | Pacemaker control software, ICD therapy delivery software, ventilator control software, drug infusion pump control software, robotic surgery control software, radiation therapy delivery systems, implantable neurostimulator programming software | Highest risk; software failure can cause death or serious injury; most stringent development lifecycle; complete requirements traceability from hazard through architecture through code through test; code coverage analysis required | Class C requires everything in Class B plus: detailed software design for all units, complete code review/inspection or static analysis, unit testing with full branch/MC/DC coverage per severity, complete regression testing for all changes; software architecture risk controls at unit level; anomaly resolution and trending required | Comprehensive_post-market_monitoring + anomaly_management | Full_SDLC_with_complete_traceability_and_code_coverage | Development_lifecycle_Class_C | Serious_injury_or_death | FDA Class III devices; high-risk Class II SaMD |
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