PMCF Under the MDR: From Strategy to Successful Implementation

Master the Foundations of PMCF Under the MDR

• Detailed introduction to Articles 83–85 and Annex III/XIV
• Overview of key MDCG guidance documents relevant to PMCF and their practical implications for planning, methodology, and documentation
• Understanding the interface between PMCF, risk management (Annex I), and clinical evaluation (Article 62, Annex XIV Part A)
• PMCF as an integral part of the PMS system

Develop and Plan an Effective PMCF Strategy

• Structure and essential elements of a PMCF Plan
• Selection of appropriate PMCF methods, including surveys, observational studies, clinical investigations, and registry data
• Definition of relevant clinical endpoints
• Involvement of internal stakeholders such as marketing, sales, and clinical affairs

Conduct and Evaluate PMCF Activities

• Designing surveys and interviews with consideration of evidence quality
• Planning and executing PMCF studies, including communication with ethics committees and submission of required documentation
• Analysis and interpretation of PMCF results
• Preparation of the PMCF Evaluation Report

Integrate PMCF Into Technical Documentation

• Using PMCF outcomes to update clinical evaluation, risk management documentation, IFUs, and product improvements
• Ensuring continuous compliance throughout the device lifecycle

This course is ideal for professionals who need a clear and actionable understanding of PMCF under the MDR. By incorporating current MDCG guidance, the training reflects the latest regulatory expectations and helps participants prepare documentation that meets Notified Body requirements. It equips participants to design effective PMCF strategies, select suitable methods, and evaluate PMCF data in a compliant manner. The training provides practical insights into integrating PMCF results into technical documentation and PMS processes, helping organizations maintain robust clinical evidence and ensure ongoing product safety and performance.