Module 15 2022

5/19/2022

Submission CER

Stage 4 Clinical evaluation report incl. PMS/PMCF plan

Stage 0 Scoping, Plan

Stage 1 Identification of pertinent data

Stage 3 Analysis of the clinical data

Stage 2 Appraisal of pertinent data

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Maintenance CER – MEDDEV 2.7.1 Rev 4 general principles

• Requirement for actively updating • At least annually if the device carries significant risks or is not yet well established; or • Every 2 to 5 years if the device is not expected to carry significant risks and is well established, a justification should be provided. • Typically aligned with NB surveillance audits and the certificate renewal • CONFIRM that there is still clinical evidence to confirm conformity with the GSPR covering clinical performance and clinical safety; • CONFIRM the device is compliant with SOTA, and assess if another device shows a better benefit/risk profile • Compile newly gathered data from PMCF activities

• However, PSUR/PMCF/SSCP cycle may result in more frequent CER updates

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