Module 16 2022

05/09/2022

 Outlined in Annex III, Technical documentation on post market surveillance  Compare to Annex X, Section 1.1(c) of the MDD  “The clinical evaluation and its documentation must be actively updated with data obtained from the PMS.”

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Annex III – Technical Documentation on Post-Market Surveillance

Annex III Technical

documentation Post Market Surveillance

1.2 Periodic Summary Update Report PSUR Article 85

1.1 Post-market surveillance plan

A Drawn up in accordance with Article 84

Post-market surveillance report Article 85

B PMS Plan should cover various requirements

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