Software as a Medical Device (SaMD) | MedTech Compliance Guide

EU requirements

Classification: Under MDR Annex VIII Rule 11, diagnostic or therapeutic decision software is Class IIa by default; it is Class III when decisions may cause death or irreversible deterioration, and Class IIb when they may cause serious deterioration or surgical intervention. Physiological-process monitoring software is Class IIa or IIb; other software is Class I.
Conformity pathway: Class I devices may be self-declared. Class IIa, IIb, and III devices require a Notified Body assessment under Annex IX or Annex X plus XI.

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01Determine classification under MDR Annex VIII Rule 11.Source: MDR 2017/745 Annex VIII
02Confirm medical-device qualification under Article 2(1) and MDCG 2019-11 rather than a wellness-app classification.Source: MDCG 2019-11
03Implement IEC 62304-compliant software lifecycle documentation.
04Conduct ISO 14971 risk management and IEC 62366-1 usability engineering.
05Engage a Notified Body for Annex IX assessment if the device is Class IIa or higher.Source: MDR Article 52
06Draft the Clinical Evaluation Report and PMS Plan, and assign a UDI.

Classification: SaMD is typically Class II; high-risk software can be Class III, while low-risk wellness software may be Class I, exempt, or subject to General Wellness enforcement discretion.
Conformity pathway: A Class II device typically uses 510(k) with a predicate. A novel low- or moderate-risk device may use De Novo, while Class III devices use PMA.

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01Determine classification and predicate availability for a 510(k).
02Assess eligibility for General Wellness enforcement discretion.Source: FDA General Wellness Policy
03Establish a Design History File aligned to IEC 62304.
04Prepare a 510(k) or De Novo submission with appropriate software documentation.Source: FDA De Novo overview
05Implement QMSR-compliant, ISO 13485-aligned design controls.Source: FDA QMSR