Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

13/04/2023

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The PEP - Annex XIII Part A

• Specifies the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence.

• The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data.

• Its depth and extent shall be proportionate and appropriate to the characteristics of the device including the risks, risk class, performance and its intended purpose.

• A Performance Evaluation Plan is required, but… ‼ If any element of the plan is not completed, because it is not appropriate due to the characteristics of the device, it should be justified.

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