Medical Device Reporting to NCAs

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	15.04.2014 11:18:48
Modified:	27.02.2018 10:38:49

Diagram Elements :

Medical Device Reporting (MDR) to NCAs

RA Specialist

Medical Device Report (MDR)

NCA - National Competent Authorities

Report to other country specific authorities

AE regarded as SAE?

Complaint report

Analysis of reported Adverse Event

FDA

BfArM

Safety representative

Reporting of AE assessed

DIMDI

Do SAE reporting to BfArM according to MPSV (for CE approved devices only!)

FDA

Do SAE reporting to FDA (for FDA approved products only!)

Reported AE