About Introduction to IVDR EU 2017/746 IN VITRO MEDICAL DEVICE REGULATION
Who can attend this course:
- Managers and Personnel responsible for the CE certification
- Regulatory Affairs officer of certification evaluation for in vitro medical devices
- Quality Assurance personnel responsible for device and system compliance
- CE certification consultant
This course enables you to understand the laws associated with the 2017/746 In Vitro Medical Device Regulation and provides you with knowledge required for editing the technical documents for medical device manufacturers.
This course pack is designed to help you to;
- Analyze the differences between the directive of IVDD and the regulation IVDR
- Understand the structure of IVDR
- Understand general safety and performance requirements.
- Gain knowledge about audit direction and process of Notified Body (NB)
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Course material is in English.
Presentation in English.
- IVDR overview and status of transition
- IVDD vs. IVDR key changes
- Scope of IVDR & key definitions
- General responsibility of manufacturers
- Economic operators
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (IVDR) vs ER (IVDD)
- IVDR performance evaluation process
- IVDR Post Market Surveillance and PMPF
- IVDR Medical Device Quality Management System
Throughout the chapters and annexes will be covered briefly and some in more detail. There will be exercises along the days.