The Medical Devices Introductory Course 2020

Clinical Evaluation - the main documents THE CLINICAL EVALUATION PLAN

The Organisation for Professionals in Regulatory Affairs

Documenting the scoping and planning stage

• MDR Annex XIV requires a CEP and lists specific minimum contents • A clinical development plan should also be included in the CEP • For class IIIs and active class IIbs intended to administer/remove a medicinal product, manufacturers can consult an expert panel (per Article 106) regarding their clinical development strategy/clinical investigation proposals • A gap analysis may also be appropriate to conduct (e.g. assessment of existing CER written to rev. 3 vs rev. 4)

The Organisation for Professionals in Regulatory Affairs