Essentials of European Medical Device Regulatory Affairs - June 2020

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 specificMS 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 clinicalplan. • 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 scheduledend of trial. If one year is not feasible this should be stated in the clinicalplan with justification.

The reports will become publicallyavailable immediately in the case of an early termination, otherwise when the device is registered or after 1 year which ever is earliest.

Adverse event reporting Record • AEs critical to the evaluation • SAEs • Device deficiencies that might have led to an SAE • Relevant new findings Report to all concerned MS (via portal) • SAE causally related to the device, comparator or procedure • Device deficiency that might have led to SAE • Events in non EU countries involved in the CI Timeline • Without delay: an initial to allow that and follow up report

If a PMCF investigation then follow marketed product reporting rules

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