Software as a Medical Device (SaMD) Compliance Checklist

Software as a Medical Device (SaMD) is software intended to be used for medical purposes — diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. This template covers MDR/IVDR classification, conformity assessment, and AI Act overlay.

Quick Answer

SaMD is regulated as a medical device under MDR/IVDR in the EU. Risk classification determines the conformity route. AI-powered SaMD must also comply with the EU AI Act High Risk requirements. ISO 13485 QMS and IEC 62304 software lifecycle are required standards. EUDAMED registration is mandatory.

Compliance Checklist (8 items)

Apply the IMDRF SaMD risk framework and MDR Rule 11 to classify your software (Class I to III)
Class IIa and above require involvement of a Notified Body for conformity assessment
Prepare a technical file including intended use, clinical evidence, risk management file per ISO 14971, and software lifecycle documentation per IEC 62304
Implement a Quality Management System (QMS) per ISO 13485 before CE marking
Register in EUDAMED — mandatory for all medical devices placed on the EU market
Apply EU AI Act High Risk obligations in parallel if the SaMD uses AI components
Maintain a post-market surveillance (PMS) plan and file; file periodic safety update reports (PSUR)
Ensure GDPR / UK GDPR compliance for all patient data processed by the software

Penalty if not compliant

Placing non-compliant SaMD on the EU market violates MDR and can result in market withdrawal, significant fines, and criminal liability for company officers. National competent authorities can order immediate market suspension.

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