The Medical Devices Introductory Course 2020

Vigilance

ISO 13485:2016

8.2.3

“…………If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices the org shall document procedures for providing notification to the appropriate regulatory authorities”

The Organisation for Professionals in Regulatory Affairs

25

Vigilance

1

European Vigilance Process Overview

OtherSources

Customer

RegulatoryAuthority (following auser report)

CustomerFacing Associate

LocalComplaintCo- ordinator

CountryRegulatory Leader

Report toNB

Report to countryCA

Manufacturer’s Complaint ManagementSystem

Manufacturer’s risk management system

EuropeanUnitRA Leader

3

2

MedicalAffairs and / orApplications Specialists,as required

MDVR DecisionTree Q: IsanMDVR required ?

EuropeanUnitRA Leader -Review& Confirmation

EuropeanCountry RegulatoryNetwork