In Vitro Diagnostic Regulation (EU) 2017/746
This two day 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 training 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.
▪ 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
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?
▪ Training course notes
▪ Meddev Solutions IVDR training course certificate