REF. CL02 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of a Medical Device’s compliance with the General Safety and Performance Requirements (GSPR) must include a clinical evaluation. This clinical evaluation consists in the planning and conduct of a critical review of the clinical data for the Medical Device (MD) under evaluation and the analysis of this data to assess the safety, performance and clinical benefits of the product considering the state of the art.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Understand the regulation’s requirements in terms of clinical evaluations
- Become familiar with the basics to draft a clinical evaluation report
TARGET TRAINEES
- Medical Device manufacturers
- Medical Device development or market operators
PREREQUISITES
No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- Work is based on applicable regulations and the MEDDEV 2.7/1 guidelines
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Clinical evaluation: context and definitions
- Terms and definitions
- Regulation (EU) 2017/745 requirements
- MEDDEV 2.7/1 revision 4 guidelines
- Become familiar with the different stages of a clinical evaluation
- Identify clinical benefits and claims
- The different sections of a CER
- Claiming equivalence: when and how?
- Sources of performance data
- Sources of safety data
- Data compilation and analysis
- Compliance with the general requirements: conclusion
- Practical examples
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 80%).
