Medical DevicesLast reviewed April 2026

IEC 62304(IEC 62304)

The international standard defining software lifecycle processes for medical device software.

Usage Examples

The SaMD was classified Class C per IEC 62304 due to potential patient harm on algorithm failure.
FDA premarket review referenced IEC 62304 compliance for the device software verification package.

What is IEC 62304?

IEC 62304 specifies the lifecycle requirements for medical device software, recognized by FDA (via CDRH guidance) and mandated under EU MDR. It defines software safety classification (Class A, B, C based on potential harm), required lifecycle activities (planning, requirements, architectural design, detailed design, implementation, integration, verification, release, maintenance), and risk management integration with ISO 14971.

Safety classification drives documentation rigor: Class A software (no injury possible) needs lean documentation; Class C (death or serious injury possible) requires full lifecycle artifacts including detailed design and exhaustive testing. IEC 62304 applies to standalone Software as a Medical Device (SaMD) and embedded software in physical devices. Compliance is demonstrated through design history files, verification and validation records, and traceability matrices.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside IEC 62304, ISO 14971, 21 CFR 820.

FDA CDRHEMAHealth Canada

When This Matters

The SaMD was classified Class C per IEC 62304 due to potential patient harm on algorithm failure.
FDA premarket review referenced IEC 62304 compliance for the device software verification package.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

IEC 62304ISO 1497121 CFR 820EU MDR

Frequently Asked Questions

Class A: no injury or damage possible. Class B: non-serious injury possible. Class C: death or serious injury possible. Classification is based on hazardous situations that could result from software failure, considered with hardware and external mitigations.

Yes. Standalone software that meets the medical device definition is subject to IEC 62304. The standard applies regardless of whether software is embedded, standalone, web-based, or mobile.

Risk management per ISO 14971 drives software safety classification per IEC 62304. The two standards are designed to work together: the device risk file identifies software-contributing hazards, which drive the 62304 class and required lifecycle rigor.