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MDCG 2019-11 Applicability (SaMD Qualification)

Overview​

MDCG 2019-11 (Guidance on qualification and classification of software under MDR 2017/745 and IVDR 2017/746) is the primary EU guidance document for determining whether software is a medical device and, if so, what class it falls into. This guidance is applicable in Switzerland and should be used as the primary reference for SaMD qualification and classification decisions under MedDO/IVDO.

Why MDCG 2019-11 Applies in Switzerland​

Because MedDO mirrors EU MDR and IVDO mirrors IVDR technically, MDCG guidance on the interpretation of those regulations applies equally to the Swiss ordinances. Swissmedic has confirmed that MDCG guidance generally applies in Switzerland. EU-designated NBs assessing devices for Swiss market access apply MDCG 2019-11 as a matter of course.

Key MDCG 2019-11 Concepts​

The qualification decision tree MDCG 2019-11 provides a step-by-step decision tree for determining whether software qualifies as a medical device. The key questions are:

  1. Is the software intended to process, analyse, create, or modify medical information?
  2. Is the action performed for a medical purpose?
  3. Does the output have clinical significance (i.e. does it influence clinical decisions)?

Software that does NOT qualify as a medical device (examples)

  • Software used purely for storage and communication of data (e.g. PACS without CAD functionality)
  • Administrative software (appointment scheduling, billing)
  • General purpose tools (office software, email)
  • "Simple search" functions that retrieve but do not analyse patient data

Software that DOES qualify as a medical device (examples)

  • Software performing diagnostic analysis on patient data
  • Software providing treatment recommendations based on patient data
  • Software monitoring patient vital signs and alerting to deterioration
  • Software calculating drug dosages based on patient parameters

Classification Under MDCG 2019-11​

Once qualified as a SaMD, MDCG 2019-11 provides classification guidance applying the MedDO Annex VIII rules (particularly Rules 11 and 22 for medical devices, and Rule 7 for IVD software). The classification is risk-based, considering the severity of harm from incorrect output and the significance of the healthcare decision driven by the software output.

Citing MDCG 2019-11 in Technical Documentation​

When preparing technical documentation for a SaMD for the Swiss market:

  • Include a qualification analysis section that references MDCG 2019-11 and explains the software's medical intended purpose
  • Include a classification rationale applying MDCG 2019-11 classification guidance alongside MedDO Annex VIII
  • Reference MDCG 2019-11 in the technical documentation where the software is characterised

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.