Module 15 2022

19/05/2022

PMCF plan

• Annex XIV, Part B, 6.2, the PMCF plan shall include at least: • The general methods and procedures that shall be applied to collect clinical data (e.g. literatures searches, vigilance database searches) • The specific methods that shall be applied (e.g. PMCF surveys, studies or investigations) • A rationale for the appropriateness of the methods applied • Reference to the relevant parts of the clinical evaluation report and risk management • The specific objectives to be addressed by the PMCF • An evaluation of clinical data relating to equivalent or similar devices • Reference to any Common Specifications or harmonised standards • A time schedule and justification for the PMCF activities, including reporting

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

19

PMCF plan

• MDCG guidance documents are available: • MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template • https://ec.europa.eu/health/system/files/2020 09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf

• MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template • https://ec.europa.eu/health/system/files/2020 09/md_mdcg_2020_8_guidance_pmcf_evaluation_report_en_0.pdf

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

20

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