Module 15 2022

20/05/2022

CEAR – PMS/PMCF

Points to note: ● Expected to provide PMS and PMCF plan and report and PSUR. ● Review of documentation against specific MDR and MDCG guidance. – Focus on proactive PMS and not just reactive. – Gathering clinical data on the device. – Addressing gaps from the CER. ● 26 May 2022 is one year after date of application. – All devices (including legacy) should be compliant to MDR post market surveillance requirements. – Legacy Class III and IIb should now have an annual PSUR available.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

15

CEAR – Summary of the Clinical Data

Points to note: • Only section where the clinical data is discussed. • When completing this report the auditor spends a huge part of assessment time on writing up the methodology. • A CER can assist this section by providing a succinct overall summary for safety and performance, before presenting the full clinical data.

• Linkage between clinical gaps here and PMCF plan.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

16

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