REF. CL08 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of the compliance of an In Vitro Diagnostic Medical Device (IVDMD) with the general requirements of Regulation (EU) 2017/746 may include a performance evaluation intended to establish or verify the scientific validity and clinical performance of a device.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Understand the requirements of Regulation (EU) 2017/746 in terms of the performance evaluation
- Become familiar with the basics to draft a performance evaluation report
TARGET TRAINEES
- Manufacturers of In Vitro Diagnostic Medical Devices
- IVDMD development or market operators
PREREQUISITES
Familiarity with the Medical Device regulation
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- Distribution of the texts presented
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Context and definitions
- Terms and definitions
- Regulation (EU) 2017/746 requirements
- Evaluation of the performance of an IVDMD
- The different characteristics
- Documents to be prepared
- Performance evaluation report
- Composition
- Goals targeted
- The different sections of the Performance Evaluation Report: What data? How to analyze it?
- Literature review methodology
- The different sources of information
- Selection and critical evaluation of the literature’s data
- Data analysis to establish the state of the art or the clinical performance of an IVDMD
- 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%).
