Module 16 2022

05/09/2022

Annex III – Technical Documentation on Post-Market Surveillance

An entirely new section

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• Requires a post-market surveillance plan

• Information on serious incidents, PSUR’s and FSCA’s • Trend reporting • Specialist or technical literature databases and / or registers • Feedback from users, distributors and importers • Publicly availability information about similar devices.

PMS plan specifics

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Systematic feedback process

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• Indicators and threshold values used in the continuous reassessment of the benefit-risk analysis and risk management process • Trend reporting • PMCF plan as referred to in Part B of Annex XIV or justification why not

• Requires the Periodic Summary Update Report referred to in article 86

The Organisation for Professionals in Regulatory Affairs

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Interactions

The Organisation for Professionals in Regulatory Affairs

12