Medical Device Risk Classes: ISO_14971
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| ISO_14971 | Severity_1_Negligible | No injury or damage to health | Temporary discomfort, pain without lasting effect, reversible minor skin irritation, brief nausea without treatment | Risk = P(hazardous situation) x P(harm|hazardous situation) x Severity; Negligible = severity level 1 in 5-point scale; typically acceptable without risk mitigation | ISO 14971 Annex C provides example severity/probability scales but manufacturers must define their own acceptable risk criteria per risk management policy | N/A | N/A | N/A | Negligible | Any_class |
| ISO_14971 | Severity_2_Marginal | Minor reversible injury | Minor injury requiring simple medical treatment, temporary hearing loss, temporary vision impairment, minor burns, easily treatable infections | Severity level 2; typically requires at least one layer of risk control; acceptable risk region in most risk matrices with low probability; reversible harm | Probability scale: 5=Frequent (>1/10) 4=Probable (1/10-1/100) 3=Occasional (1/100-1/1000) 2=Remote (1/1000-1/100000) 1=Improbable (<1/100000); risk matrix cells are manufacturer-defined | N/A | N/A | N/A | Low | Any_class |
| ISO_14971 | Severity_3_Serious | Significant reversible or irreversible injury | Hospitalization required, bone fracture, severe blood loss, permanent partial disability, second/third degree burns requiring hospitalization, permanent hearing loss | Severity level 3; usually unacceptable risk without risk reduction; ALARP (As Low As Reasonably Practicable) region; must demonstrate risk reduction to broadly acceptable level | Risk control measures required for Severity 3; residual risk evaluation must show benefit outweighs risk; FMEA/FTA required; post-market surveillance of risk controls effectiveness per EN ISO 14971 Annex A | N/A | N/A | N/A | Moderate | IEC_62304_Class_B_or_C |
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