IMDRF
Safety Information http://www.imdrf.org/safety/safety.asp
歐盟
http://ec.europa.eu/growth/sectors/medical-devices/guidance_en
MEDDEV 2.7 Clinical investigation, clinical evaluation
- MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies, June 2016 https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
Appendix 1: Clinical evaluation on coronary stents (100 kB), December 2008 http://ec.europa.eu/DocsRoom/documents/10324/attachments/2/translations\
- MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC, September 2015
- MEDDEV 2.7/3 rev. 3 (383 kB) Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC – SAE reporting form (27 kB), May 2015
- MEDDEV 2.7/4 (183 kB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies, December 2010