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.

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