Module 15 2022

19/05/2022

Re-cap of the clinical evaluation process

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

3

Re-cap of the clinical evaluation process

• Article 2 (44) provides the definition for clinical evaluation:

• ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; • It is a continuous process for the lifetime of the medical device • It aims to demonstrate that there is sufficient clinical data; an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions [1] • The evaluation may identify gaps in the clinical data • Gaps can be addressed by a pre-CE clinical investigation, a post-CE clinical investigation (PMCF investigation) or a combination of the two

[1] MEDDEV 2.7/1 Rev 4, Page 8

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

4

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