REF. RL15 – INTRA / INTER
EUROPEAN REGULATIONS
COURSE DESCRIPTION
To place In Vitro Diagnostic Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017/746 must be met.
The Technical Documentation the manufacturer must draw up and present must be clear, organized and unambiguous, in a form that can be easily read, and include, in particular, the items listed in Annexes II and III of the MDR.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Identify requirements to draw up the Technical Documentation according to Regulation (EU) 2017/746
- Know how to draw up the Technical Documentation and ensure it is up to date
- Integrate the Technical Documentation requirements into the design process
TARGET TRAINEES
Manufacturers of In Vitro Diagnostic Medical Devices, and more particularly:
- Regulatory Affairs
- R&D
- Any individual involved in the preparation or review of the technical documentation
PREREQUISITES
Familiarity with Regulation (EU) 2017/746 is a plus.
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Experience sharing
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Regulatory review
- Technical documentation objectives
- Technical documentation structure and format
- The basic elements and ties to the design and production file
- Content of the different sections
- File coherence: key points
- The roles that contribute to the compilation of the technical documentation
- Tie to the ISO 13485:2016 quality management system: post-market surveillance – Change control
- Notified body sampling of technical documentation reviews
- 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%).
