Module 18 2021

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2/9/2021

Lifetime Data

The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: (a) confirming the safety and performance of the device throughout its expected lifetime , MDR Annex XIV Part B

What is your claimed lifetime?

Does your clinical data reflect this?

If not how will you collect this data?

Quantification of Risks and Benefit over lifetime is required.

Clinical Evaluation of Software MDCG 2020-1

If the MDSW is used for the determination of a patient’s future state (e.g. predisposition, prognosis, prediction) or If the output of the MDSW impacts clinical outcomes (e.g. treatment efficacy) or patient management decisions, then a prospective study may be required as part of the device’s CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)

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