REF. RL22 – INTRA / INTER
EUROPEAN REGULATIONS
COURSE DESCRIPTION
To place Medical Devices on the market in Europe, the requirements of Regulation (EU) 2017/745 must be met.
The manufacturer must design and manufacture its devices so as to ensure that, under normal conditions of use, they are suited for their intended use, safe and effective, and do not endanger the clinical condition or safety of patients or the safety or health of users.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand and apply the general safety and performance requirements
- Demonstrate GSPR compliance
- Take GSPR into account during the design process
TARGET TRAINEES
Medical Device manufacturers, and more particularly:
- Regulatory Affairs
- R&D
- All individuals involved in the device’s design process
PREREQUISITES
Familiarity with Regulation (EU) 2017/745 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 framework
- General safety and performance requirements (GSPR)
- General information
- Tie to design and development
- Tie to risk management
- Tie to the technical documentation
- Evidence to prove/demonstrate compliance
- GSPR review and responses
- General requirements
- Design and manufacturing requirements
- Requirements relative to information provided with the device
- 4. Summary/Q&A
- 5. 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%).
