Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

What is a clinical evaluation?

MedDev 2.7/1 definition:

Clinical evaluation: a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use. a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use. clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the

Sufficient clinical evidence: an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions

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The Organisation for Professionals in Regulatory Affairs

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Clinical evidence Definition

• Sufficient clinical evidence: an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions

Amount: • Number of patients, centres, surgeons, etc • All device variants

Quality: • Levels of evidence and weighting • Study design and sources of bias • All relevant sources of data included • Statistical evaluation against appropriate benchmarks

• All safety and performance endpoints • All patient populations, indications, end stage and severity of disease

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The Organisation for Professionals in Regulatory Affairs

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