Other sectors

Introduction to IVDR EU 2017/746 IN VITRO MEDICAL DEVICE REGULATION

Risk Management ISO 14971:2012

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.

Kontakt os for yderligere information

Do you have any questions?

Contact us

Register for the training class here

REGISTER

Hvornår:

23. oktober - 25. oktober 2024

Add to calendar 2024/10/23 09:00 2024/10/25 18:00 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.
https://www.dnv.dk/training/introduction-to-ivdr-eu-2017-746-in-vitro-medical-device-regulation-252346
This only adds the event to your calendar, please remember to register for this event.
false YYYY/MM/DD akeGphYOczrmtQTfhmEQ22349

Varighed:

Duration: 3 days

Pris:

Course fee: DKK 20.400,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnv.dk/betingelser

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.

Interne kurser for din virksomhed

Kontakt os