Norway

RegulationsStandardsOther relevant documents

• In Vitro Diagnostic Device Regulation (IVDR) Regulation (EU) 2017/746 on in vitro diagnostic medical devices
• General Data Protection Regulation (GDPR) Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data
• The Cyber Resilience Act (CRA) Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements

• ISO 13485:2016 Medical devices --- Quality management systems --- Requirements for regulatory purposes
• ISO 14971
• ISO/IEC 27001:2022 Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements
• ISO/IEC 27701:2019 Security techniques

• MDCG 2019-16 Medical Device Coordination Group: Guidance on Cybersecurity for medical devices
• NORMEN: Code of conduct for information security and data protection in the healthcare and care services sector