Module 12 Presentations

29/01/2024

Clinical Evaluation

• Definition • ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

Device Clinical Investigation

Equivalent Device Clinical Investigation

Peer reviewed Scientific literature

PMS- PMCF Clinical information

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Clinical Evaluation

When • All along the life of the product • To be updated regularly

Who • Qualified persons • Clinician (Research Methodology) •Biostatistician (Meta-analysis) • QA/RA (Regulation requirements) • Medical writer (PhD)

How • Method: MEDDEV 2.7/1 Rev 4 • Guide MDCG 2020-13

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