IVDR-certified Probes
The certification under the In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) is mandatory for manufacturers of in vitro diagnostic devices (IVDs). The IVDR replaces the In Vitro Diagnostics Directive (EU) 98/79/EC (IVDD).
ZytoVision received the IVDR certification in May 2024 and has already started the transition of its portfolio. In line with our commitment to conformity and compliance, we have listed below the Class C products that are already IVDR-labeled and meet the latest and strictest EU requirements:
| Product | Legal Manufacturer | Amount | Status | Order no. |
|---|---|---|---|---|
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What does it mean for you?
We will continue to offer you a large portfolio of CE/IVD-certified probes that meet the highest production and quality standards.
You can continue to use our probes in diagnostics without having to perform time-consuming validations as long as you comply with the intended purpose.
Accuracy and reliability in diagnostics: increased patient safety due to the high quality standards of the products
Risk minimization
More about our IVDR journey
We are now continuously switching our probes to IVDR status.
No action required from your side: product names and order numbers remain the same.
Although many probes are already IVDR certified, we currently continue to offer you IVDD probes for parts of the IVDR portfolio. This complies with IVDR regulations.
Stay tuned for continuous updates on the development of our IVDR product portfolio.
We will continuously notify you about all IVDR probe releases.
Do you have questions?
Our scientific product management team will be happy to advise you!
