REF. RL21 – INTRA / INTER
EUROPEAN REGULATIONS
COURSE DESCRIPTION
The demonstration of an In Vitro Diagnostic Medical Device’s compliance with essential requirements requires the implementation of a post-market surveillance system 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 (PMPF)
TARGET TRAINEES
- Manufacturers of In Vitro Diagnostic Medical Devices
- IVDMD development or market operators
PREREQUISITES
- No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Experience sharing based on the regulation and related guidelines
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Post-market surveillance: context and definitions
- Terms and definitions
- Objectives
- Identification of regulatory requirements
- Regulation (EU) 2017/746
- Practical guidelines
- Documents to be drafted
- PMS and PMPF plans
- Post-market surveillance report
- Periodic safety update report (PSUR)
- Ties between the documents
- Post-market surveillance data
- What data?
- How to analyze/use it?
- Drawing up the different documents
- Practical examples
- Summary/Q&A
- Training 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 >= 75%).
