Essentials of European Medical Device Regulatory Affairs

Sources of PMS from NB-MED/2.12 Inputs

Pro-active

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 product monitoring system

Recalls

Corrective action Design changes New Risks New IFU New Clinical New submission

Advisory Notices

Complaints

MDR / Vigilance / Incident

Vigilance report (to EU & LRQA)

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

Post Market Clinical Follow-up

TERMINOLOGY  Post Market Clinical Follow-up (PMCF) study – a study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety and performance (i.e. residual risks) of a device when used in conjunction with its approved labelling [MEDDEV 2-12/2 rev 2 2012]. PMCF studies should be based on a PMCF plan. Where PMCF as part of the PMS plan for the device is not deemed necessary, this must be duly justified and documented [MDD 93/42/EEC Annex X para 1.1c].