REF. RL12 – INTRA / INTER
EUROPEAN REGULATIONS
COURSE DESCRIPTION
The design, production and marketing of Medical Devices in Europe must comply with the requirements of Regulation (EU) 2017/745.
Operators in this market must be able to evaluate the impact of these requirements on their products’ compliance, the information to be provided in the technical files and how it is organized so as to define an action plan to ensure compliance.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand the regulatory framework for MDs – learn the basics.
- Identify the impacts on the products and regulatory documents.
- Identify the impacts on the organization (responsibilities, UDI).
- Raise the awareness of attendees on the role they play.
TARGET TRAINEES
Medical Device manufacturers/subcontractors, and more particularly:
- R&D team
- Production
- Purchasing
- Sales
- Regulatory Affairs
- Quality Management
PREREQUISITES
- Familiarity with the Medical Device sector
- Familiarity with Regulation (EU) 2017/745 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) 2017/745
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Purpose and scope – definitions
- Economic operators/Individual responsible for ensuring compliance with the regulation
- Traceability/identification/registration of MDs: EUDAMED and UDI
- Classification/conformity assessment
- General safety and performance requirements
- Clinical data
- Post-market and market surveillance, vigilance
- Technical documentation
- Technical documentation on the device
- Post-market surveillance technical documentation
- Roadmap
- 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%).
