In Vitro Diagnostic Regulation (EU) 2017/746
This two day virtual instructor-led IVDR training course focuses on the application of the key principles and practices required for the new In Vitro Diagnostic Medical Devices Regulation. The IVDR will replace the current EU Directive on in vitro diagnostic medical devices (98/79/EC) and will be effective in all EU member and EFTA states.
During this two day virtual course, you will gain an appreciation for the changes and new requirements of the IVDR and take away practical skills and guidance on how to transition to the new regulation.
Unlike many other online trainings, we encourage you to bring and ask as many questions as you like! This is the best way to embed your knowledge and gain a thorough understanding. We are here to help you make your medical devices compliant.
This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.
▪ Routes to conformity
▪ Performance evaluation
▪ Risk analysis and trending
▪ The Unique Device Identifier (UDI)
▪ Safety and performance requirements
▪ Classification and recognition of devices
▪ Post-market surveillance and associated reports
▪ Requirements for manufacturers and economic operators
You have the opportunity to ask as many questions as you like to our expert trainers throughout the course.
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
Due to the nature of the course, an exact time of each topic can not be provided.
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
Who should attend?
This course has been designed to enhance the level of understanding for those actively engaged with IVDs and placing them on the market.
▪ Quality Assurance professionals
▪ Quality Engineers
▪ Research and Design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
What will I receive?
▪ PDF training course notes, slides and handouts
▪ The opportunity to get your questions answered!
▪ Full tutor support