Essentials of European Medical Device Regulatory Affairs

Post Market Surveillance PMS

What is Post market surveillance?

• ‘all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions ’

The Organisationfor Professionals inRegulatory Affairs

Post Market Surveillance PMS The PMS System • Requirement for all manufacturers

• Appropriate for the device and risk class • Active, systematic continuous process: – Gathering quality, performance and safety data – Recording – Analysing – Reaching conclusions – Determining, implementing, monitoring CAPAs – Feedback into other processes • PMS plan and reports

The Organisationfor Professionals inRegulatory Affairs