Essentials of European Medical Device Regulatory Affairs - October 2019

Post Market Surveillance Lifecycle

143

Sources of PMS

Pro-active

Inputs

Outputs

Technical Literature reviews Client investigations – failure analysis Registries (implants) Active device tracking Post CE clinical trials Experience on equivalent devices Maintenance reports Quality Control Testing Service Returns Warranty Claims Repairs Field Service User reactions during training programmes Internal Product audits Other bodies (the CA)

Manufacturers QMS:

Vigilance report

PMS

Updated IFU Design and /or Manufacturing changes New Clinical study New submission

Complaint handling Vigilance

FSCA

Risk Management Clinical Evaluation CAPAs Design Manufacture

FSN

Sales / Marketing Customer surveys Sales Call Feedback Post market study Reps or Distributor Feedback Experts user groups The Media Social Media – Patient Groups

144