Essentials of European Medical Device Regulatory Affairs

Sources of PMS

Pro-active

Outputs

Inputs

Manufacturers QMS:

Technical Literature reviews Client investigations – failure analysis Registries (implants) Active device tracking Post CE clinical trials Experience on equivalent devices Maintenance reports

PMS

Complaint handling

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

Vigilance report

Vigilance

Quality Control Testing

Internal Product audits Other bodies (the CA)

Risk Management

FSCA

Service Returns Warranty Claims Repairs Field Service User reactions during training programmes

Clinical Evaluation

FSN

CAPAs

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

Design

Manufacture

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Post Market Surveillance PMS

Post Market Surveillance Plan (Annex III):

Collection of information

•

• Characterisation of the performance of the device • Comparison with similar products • Suitable indicators and thresholds for risk benefit analysis • Methods /tools/protocols:

– to investigate complaints – Analysis of trends – Communication with CAs, NBs, EOs and users – Tracing devices

PMCF plan

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