Essentials of European Medical Device Regulatory Affairs

Why conduct a Clinical Evaluation?

• Demonstrate that the device complies with the relevant General safety and performance requirements (Annex I, MDR) • Device is suitable for intended purpose during normal conditions of use • Safe and effective • Foreseeable risk are minimised & acceptable when weighed against the benefits of performance • Clinical performance & safety claims are supported by evidence

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Stages of Clinical Evaluation

Published literature

Clinical investigations

Clinical experience

Generate new or additional clinicaldata

Systematic literature search

NO

Produce clinical evaluation report (CER)

Sufficient clinical evidence?

Appraisal of data

YES

Analyse data performance/safety conclusions?

Declaration of conformity

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