REF. CL10 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of an In Vitro Diagnostic Medical Device’s compliance with the General Safety and Performance Requirements includes the implementation of Post-Market Performance Follow-up (PMPF) to collect, record and analyze relevant data on the quality, performance and safety of a device throughout its lifecycle. This system must be documented and implemented in accordance with the requirements of Regulation (EU) 2017/746.
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 post-market surveillance and post-market performance follow-up
- Become familiar with the different options regarding post-market performance follow-up activities
TARGET TRAINEES
- IVDMD manufacturers
- IVDMD development or market operators
PREREQUISITES
No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Discussions based on the regulation and guidelines
- Distribution of the texts presented
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Post-market performance follow-up: context and definitions
- Terms and definitions
- Process inherent in post-market surveillance
- Goals
- Identification of regulatory requirements
- Regulation (EU) 2017/746
- Practical guidelines
- Nature of PMPF activities
- Documents to be prepared
- PMPF plan
- PMPF report
- Post-market performance data
- What data?
- How to analyze/use it?
- Implementation of the different documents and related documents
- 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%).
