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References

International Norms and Standards

  • ISO-15189: Medical laboratories — Requirements for quality and competence
  • IEC-62304: Medical device software – software life cycle processes
  • ISO-14971: Medical devices — Application of risk management to medical devices
  • ISO-22367: Medical laboratories — Application of risk management to medical laboratories
  • ISO-27001: Information security management systems

European Laws and Guidances

  • IVDR, REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
  • MDCG 2019-11 Guidance on Qualification and Classification of Software in MDR and IVDR
  • Infographic, Is your software a Medical Device?
  • MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
  • MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices
  • MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

Publications

  • van Deutekom HWM, Haitjema S. Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases. Clin Chem Lab Med. 2022. PMID: 35538674.
  • Bank PCD, Jacobs LHJ, van den Berg SAA, van Deutekom HWM, Hamann D, Molenkamp R, Ruivenkamp CAL, Swen JJ, Tops BBJ, Wamelink MMC, Wessels E, Oosterhuis WP. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications. Clin Chem Lab Med. 2020 Nov 23. PMID: 33554568.

Other

  • Guidance document for MRECS
  • IMDRF/SaMD WG/N12FINAL:2014 "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Consideration