Essentials of European Medical Device Regulatory Affairs

CE marked devices – used per label but additional procedures (article 74) E.g. Post market clinical follow up (PMCF) studies

In the case of implantable devices and class III devices, where clinical investigations have not been performed, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device. Article 61(4) Sponsor notifies MSs via at least 30 days prior to study start. Electronic system PerArticle73

End of clinical investigation (Article 77) Temporary halt or early termination • Sponsor informs specific MS within 15 days with justification • If halted for safety reasons inform all concerned MS within 24 hours Scheduled end of the CI • End of CI = LPV unless defined otherwise in the clinical plan. • inform MS of their LPV within 15 days • Multi country study inform all MS of the LPV of all MS with 15 of the last LPV. Submit Clinical investigation report (signed by PI) and summary (suitable for the intended user) 3 months from early termination, one year from scheduled end of trial. If one year is not feasible this should be stated in the clinical plan with justification. The reports will become publically available immediately in the case of an early termination, otherwise when the device is registered or after 1 year which ever is earliest.