Introduction to the In-Vitro Diagnostic Regulation (IVDR) is a course dedicated to requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746.
Topics
How the role of the Notified Body will change under the IVD regulation
The new IVD regulation
Planing labelling requirements and strategies
The requirements of the Technical Documentation for an IVD
How IVDSs are classified
The key changes to ISO13485
The vigilance and Post Market Surveillance (PMS) requirements for IVDS
The requirements for clinical evidence
Who should Attend
Persons responsible for regulatory compliance
Regulatory affairs personnel
Those responsible for OEM/Subcontractor control of IVDs
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 05-06 Feb 2025, Webinar (100445)
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 16-17 Jul 2025, Webinar (76570)
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 04-05 Nov 2025, Webinar (76588)
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - Mar 2026, (76589)
Past Events
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 05-08 Nov 2024, Webinar (84399)
Introduction to the In-Vitro Diagnostic Regulation (IVDR) - 24-25 Jul 2024, Webinar (83782)
Important
Please, check "Introduction to the In-Vitro Diagnostic Regulation (IVDR)" official website for possible changes, before making any traveling arrangements
