Essentials of European Medical Device Regulatory Affairs - June 2020

Guidance

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

TheOrganisation for Professionals in Regulatory Affairs

Chapter VII Postmarket surveillance vigilance and market surveillance

Articles 83-100

Annex III

Technical documentationonpost market surveillance (PMS)

TheOrganisation for Professionals in Regulatory Affairs

Post Market Surveillance PMS

What is Post market surveillance?

• to keep up to date a systematic procedure to proactively collect and review experience gained from devices placed on the market

• Collect from activities carried out by manufacturers in cooperation with other economic operators

• for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions

TheOrganisation for Professionals in Regulatory Affairs

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