NLMedicalDevices object
Applicable national regulations
National Act on Medical Devices
Act on Medical Devices (or comparable national legal framework)
Regulation of 15 December 2005 no 1690 on medical devices § 4-5, § 5-6, Annex/vedlegg AIMU I, AIMU VI, AIMU VII, ØMU I, ØMU VIII, ØMU X) (In Norwegian)
Additional Information
International regulatory framework and guidance documents
• Directive 93/42/EEC (Article 15, Annexes I, VIII, X), directive 90/385/EEC (Article 10, Annexes 1, 6, 7)
• MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and notified bodies (incl. Appendix 1 Clinical Evaluation of Coronary Stents)
• MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation notification
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
