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Clinical Investigation and Evaluation

Guidelines on Clinical investigation: a guide for manufacturers and notified bodies, MEDDEV 2.7/4(180 KB)
Guide for Competent Authorities in making an assessment of clinical investigation; notification, MEDDEV 2.7/2(37 KB)
Explanatory document for Compentent Authorities, manufacturers and sponsors:
EUDAMED identifier system for Clinical Investigations(14 KB)
International standard. EN ISO 14155:2011.
Harmonised standards give presumption of conformity with the essential requirements of a given directive. The use of standards is not mandatory, however, if other means of compliance are used it shall be demonstrated that the essential requirements are met. EN ISO 14155:2011 “Clinical investigation of medical devices for human subjects – Good clinical practice”, gives practical guidance on the conduct and reporting of clinical investigations. EN ISO 14155:2011 has been published in the Official Journal of the European Union (OJ C123 of 27 April 2012) and is therefore a harmonised standard.

Guidelines on clinical investigations: serious adverse event reporting under directives 90/385/EEC and 93/42/EC, MEDDEV 2.7/3(166 KB)
MEDDEV 2.7/3 Appendix: SAE reporting form(87 KB)
Incidents occuring following the placing of devices on the market should be reported in accordance whith MEDDEV 2.12/1(297 KB). This reporting obligation also includes incidents occuring during post market clinical investigation of CE marked devices used for the intended purpose.

Clinical evaluation: Guide for manufacturers and notified bodies, MEDDEV 2.7/1(378 KB)
MEDDEV 2.7/1 Appendix 1(101 KB): Clinical evaluation on coronary stents
MEDDEV 2.12/2 rev.2(221 KB) Post Market Clinical Follow-up Studies