REF. CL07 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of the product’s compliance with the general requirements of Regulation (EU) 2017/746 may include a clinical performance study, which is intended to produce data to clinically establish or confirm the analytical performance of a device. This course’s objective is to identify the regulatory obligations relative to the implementation and conduct of a clinical performance study.
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 and ISO 20916 regarding good practices for clinical performance studies
- Identify the essential documents required
- Become familiar with the basics to design and conduct a clinical performance study
TARGET TRAINEES
- Manufacturers of In Vitro Diagnostic Medical Devices (IVDMD)
- IVDMD 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
- Reference to Regulation (EU) 2017/746 (IVDR) and ISO 20916
- 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
- Regulatory and legal requirements
- Ethical considerations
- When should a clinical performance study be conducted?
- Study design
- The different types of studies
- Design parameters
- The essential documents required
- Study conduct
- Submission and regulatory evaluation of the study
- Conditions to be met to conduct the study
- Study conduct
- Monitoring quality
- Clinical performance study report
- 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%).
