In Vitro Diagnostic Regulation Training

ABOUT THE COURSE

This 1-day IVDR training course will provide a brief overview of the European Regulation 2017/746 related to in vitro Diagnostic Devices.

IVDR will replace the EU's current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to May 26, 2022 to meet the requirements of the IVDR. Products already certified by a Notified Body may be placed on the market for further 2 years under the following conditions:

1) The certificate issued under the IVDD is still valid;
2) The device continues to comply with the directive and
3) No significant changes in design and intended purpose

Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by training and retraining staff over the next few years. Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation.

Duration: 1 - day course
Language: English

WHAT WILL YOU LEARN FROM THE COURSE?

Topics to be covered in this course include:

• IVD Regulation - Introduction
• Obligations of economic operators
• Classification of IVD medical devices
• Conformity assessment procedures
• Technical documentation 
• Performance requirements
• Traceability requirements
• Post-Market Surveillance, vigilance and market surveillance requirements
• Transition Timeline

WHAT IS THE COURSE METHODOLOGY?

Participants will learn through lectures and discussions.

WHO SHOULD TAKE THE COURSE?

This course is specially designed for:

• Newcomers in the medical device industry
• Expert and executive personnel to update their knowledge
• Personnel in charge of regulatory affairs
• Personnel in quality management
• Consultants in the medical device industry

Prerequisite: None

WHO IS THE COURSE ADVISOR?

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.