Clinical Evaluation of Medical Devices - According to Regulation (EU) 2017/745
This course provides a comprehensive and practice oriented introduction to the clinical evaluation of medical devices under Regulation (EU) 2017/745. Participants learn how to apply MDR requirements, relevant MDCG guidance documents, and the methodological expectations of MEDDEV 2.7/1 rev. 4. The training explains how to evaluate clinical data related to safety, performance and the clinical benefit, and how to document the results in a clinical evaluation report and the technical documentation. Practical examples illustrate how to conduct systematic literature searches, address challenges regarding the demonstration of equivalence, and plan PMCF activities as part of the continuous update cycle of the clinical evaluation.
Course Outline
- MDR requirements for clinical evaluation
- Relevant MDCG guidance documents and their practical implications
- Role and continued relevance of MEDDEV 2.7/1 rev. 4
- Clinical evaluation across the product lifecycle
- Structure and contents of a CER
- Systematic literature search methods and tools
- Assessment of equivalence and related common challenges
- PMCF planning and continuous generation of clinical evidence
- Integration with technical documentation and risk management
- Practical examples and templates
Learning Outcomes
Regulatory Requirements
- MDR requirements for clinical evaluation
- Relevant MDCG guidance documents (e.g., MDCG 2020 6, 2020 13, 2020 5)
- Continued relevance of MEDDEV 2.7/1 rev. 4
- Expectations regarding clinical evidence and PMCF
Clinical Evaluation across the Product Lifecycle
- Integration of clinical evaluation into development, market access, and post market phases
- Continuous updating of clinical evidence
- Planning and implementing PMCF activities
Structure and Content of a Clinical Evaluation
- Required contents of a Clinical Evaluation Report (CER)
- Safety, performance, clinical benefit, and usability considerations
- Demonstrating equivalence — challenges and limitations
- Interfaces with technical documentation and risk management
Practical Tools and Methods
- Templates for clinical evaluation plans and reports
- Workshop on systematic literature searches (e.g., Embase, PubMed)
- Data appraisal and weighting of clinical evidence
- Documentation requirements and best practices
Who Should Attend
This course is designed for professionals seeking a clear, practical understanding of clinical evaluation under the MDR. It covers the structure of compliant CERs, systematic literature searches, and the integration of findings into technical documentation. The training also provides practical insights into MDCG expectations, challenges in demonstrating equivalence, and PMCF planning.
Why You Should Attend
NSF has many years of experience in conducting clinical evaluations, with first-hand experience gained through direct contact with notified bodies and a wide range of customers. In addition, NSF is involved in the creation of international standards for clinical evaluation. Learn from very experienced authors of clinical evaluations with extensive practical and regulatory knowledge.
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