Clinical development plan

The EU MDR asks for a clinical development plan as part of the clinical evaluation plan. It helps show the notified body that evidence gaps are known and that the studies to close them are planned with milestones.

A plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations and a PMCF with an indication of milestones and a description of potential acceptance criteria.

MDCG 2020-1, Section 3.3, Definitions (MDR; source: EU 2017/745 (MDR), Annex XIV, part A)