Bibliography

Standards, regulations, and references cited across blog posts — and own publications as they appear.

Own publications

  • No publications listed yet.

Medical device regulation

  • European Parliament and Council. 2017. Regulation (EU) 2017/745 on medical devices (MDR). Official Journal of the European Union.
    eur-lex.europa.eu ↗
  • Medical Device Coordination Group (MDCG). 2019 (rev. June 2025). MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. European Commission.
    health.ec.europa.eu ↗
  • International Electrotechnical Commission. 2006. IEC 62304: Medical device software — Software life cycle processes. IEC.
    iso.org ↗
  • International Electrotechnical Commission. 2015. IEC 62366-1: Medical devices — Application of usability engineering to medical devices. IEC.
    iso.org ↗
  • International Organization for Standardization. 2016. ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes. ISO.
    iso.org ↗
  • International Organization for Standardization. 2019. ISO 14971: Medical devices — Application of risk management to medical devices. ISO.
    iso.org ↗

Data protection

  • European Parliament and Council. 2016. Regulation (EU) 2016/679 — General Data Protection Regulation (GDPR), Article 9: Processing of special categories of personal data. Official Journal of the European Union.
    gdpr-info.eu ↗
  • European Parliament and Council. 2016. GDPR Article 35: Data protection impact assessment. Official Journal of the European Union.
    gdpr-info.eu ↗

AI regulation

  • European Parliament and Council. 2024. Regulation (EU) 2024/1689 — EU Artificial Intelligence Act (Article 3, Article 6, Recital 12). Official Journal of the European Union.
  • European Commission. February 2025. Commission guidelines on the definition of an AI system under the EU AI Act. European Commission.

CE marking

Further reading

  • To be populated.