Medical Device Risk Classes

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.