IVDR – In Vitro Diagnostic Regulation
A Regulation to ensure safety and efficacy of in vitro diagnostic devices
Two new regulations were adopted in the EU for medical devices and in vitro diagnostic devices that aim to ensure better protection of public health and patient safety. One of those is the In Vitro Diagnostic Regulation (IVDR) that replaces the existing In Vitro Diagnostic Directive (IVDD).
All manufacturers, authorized representatives, importers and distributors of IVDs in the EU need to comply with these regulatory requirements.
Zyagnum AG shares the ambitions of the IVDR. Indeed, this regulation, by setting high standards of quality and safety, aims to guarantee the proper functioning of devices on the European market and to ensure a high level of health protection for patients and users.
The major changes introduced by IVDR compared to the previous IVDD
- Increased involvement of Notified Bodies
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New classification of IVD devices in 4 classes of risk:
- Class A: Low patient and public health risk.
- Class B: Moderate individual risk and/or low public health risk.
- Class C: High individual risk and/or moderate public health risk.
- Class D: High individual risk and high public health risk.
- Demonstration of the clinical evidence of devices (based on Performance Evaluation Report)
- More stringent Post Market Surveillance and Vigilance requirements
- Clarification of obligations of economic operators (manufacturers, authorized representatives, importers and distributors)
- Increased transparency with information being made public in a new European Database on Medical Devices (EUDAMED)
In July 2026, Zyagnum AG completed all its QMS IVDR certifications and the CE marking for PanTum Detect®.