REF. RL24 – INTRA / INTER
EUROPEAN REGULATIONS
COURSE DESCRIPTION
When in vitro diagnostic medical devices (IVDMD) are placed on the market in Europe, the post-market phase must be supervised, in particular via the collection and analysis of adverse events, so that any action required to protect the safety of patients, users and third parties can be taken.
Regulation 2017/746 requires operators in this market to implement and maintain notification processes for serious incidents and corrective safety measures as part of their vigilance obligation.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand the regulatory framework for IVDMDs; learn the basics
- Identify the impacts on the organization of feedback processing and the implementation of corrective actions
- Identify the impacts on the organization (responsibilities, information channels – collection and processing)
- Raise the awareness of attendees on the role they play
TARGET TRAINEES
IVDMD manufacturers/subcontractors, and more particularly:
- Regulatory Affairs
- Quality Management
PREREQUISITES
- Familiarity with the IVDMD sector
- Familiarity with Regulation (EU) 2017/746 may facilitate a better understanding of its requirements
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Distribution of Regulation (EU) 2017/746
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Context
- Objectives and requirements – the regulation
- A few definitions
- Who is concerned?
- In vitro diagnostic medical device vigilance
- General principle
- Feedback analysis
- Manufacturer’s Incident Report (MIR)
- IMDRF codes
- FSN and FSCA
- Communication – Reports
- 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 >= 75%).
