Introduction to IVDR EU 2017/746 IN VITRO MEDICAL DEVICE REGULATION
The In Vitro Medical Device Regulation (2017/746) entered into Force in 2017 and has date of application May 26, 2022. This course provides a knowledge of the requirements of the regulations including the requirements for Technical Documentation and Quality system requirements.
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
Course Objectives:
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)
Course Leader:
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.
Language:
Course material is in English.
Presentation in English.
Course agenda:
Day 1:
- IVDR overview and status of transition
- IVDD vs. IVDR key changes
- Scope of IVDR & key definitions
- General responsibility of manufacturers
- Economic operators
- UDI
Day 2:
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (IVDR) vs ER (IVDD)
Day 3:
- IVDR performance evaluation process
- IVDR Post Market Surveillance and PMPF
- Vigilance
- IVDR Medical Device Quality Management System
- QUIZ
Throughout the chapters and annexes will be covered briefly and some in more detail. There will be exercises along the days.
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
Course Objectives:
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)
Course Leader:
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.
Language:
Course material is in English.
Presentation in English.
Course agenda:
Day 1:
- IVDR overview and status of transition
- IVDD vs. IVDR key changes
- Scope of IVDR & key definitions
- General responsibility of manufacturers
- Economic operators
- UDI
Day 2:
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (IVDR) vs ER (IVDD)
Day 3:
- IVDR performance evaluation process
- IVDR Post Market Surveillance and PMPF
- Vigilance
- IVDR Medical Device Quality Management System
- QUIZ
Throughout the chapters and annexes will be covered briefly and some in more detail. There will be exercises along the days.