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.
Introduction to the In-Vitro Diagnostic Regulation (IVDR) covers topics such as:
- 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
Introduction to the In-Vitro Diagnostic Regulation (IVDR) brings together:
- Persons responsible for regulatory compliance
- Regulatory affairs personnel
- Those responsible for OEM/Subcontractor control of IVDs
- Quality assurance professionals
- Economic operators, importers, distributors
Introduction to the In-Vitro Diagnostic Regulation (IVDR) will be held on 07-08 Mar 2024.
