Module 18 2021

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2/9/2021

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. t odologically sound n oing procedure to collect, appraise and analyse clinical d ta per aining to m d al device and to evaluate whether there is suffi ient clinical evide ce to confirm omplianc with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instruction for Use. ing procedure to o lect, a praise and an lyse clinic l data pertaining to a medical d vice and to v luate w ether th re is sufficient clinical evidence t confirm compliance with relevant essential equirement for safety and performanc whe using the fficient clinical evid nce to confirm complianc with relevant e sential requi ements for sa ety a d performance when using the device co ding to the manufacturer’s Instructions for Use. nfir ompliance with re evant sential equirements for safety a d p rformance when sing the device according o the manufacturer’s Instructions for Use. he using the device according to the manufactur r’s tructions for Use.

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

Clinical evidence Definition

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

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

Amount: • Number of patients, centres, surgeons, etc • All device variants • All safety and performance endpoints • All patient populations, indications, end stage and severity of disease

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