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http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

MEDDEV  2.7 Clinical investigation, clinical evaluation

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