Module 15 2022

19/05/2022

MDR PMS requirements - planning

Article 85 • Manufacturers of Class I medical devices shall present PMS data in a post-market surveillance report (PMSR) • A PSUR is not required for Class I devices

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

13

MDR PMS requirements - planning

Article 86 • Manufacturers of Class IIa, IIb and III medical devices shall present the PMS data in a Periodic Safety Update Report (PSUR)

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

14

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