IVDR-Certified Portfolio
We are excited to share that more than 200 products from our portfolio are IVDR certified!
As a manufacturer of CE/IVD products, we consider compliance with the In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) to be of utmost importance - and not merely a challenge. We aim to meet the highest quality standards, and we are committed to make a valuable contribution to improving patient care and safety.
By following our mission, to be your partner of trust and In line with our commitment to conformity and compliance, we remain focused on extending our IVDR certified portfolio!
You can find the already IVDR-labeled products that meet the latest and strictest EU requirements below.
And this is just the beginning - many more products will follow soon!
Future-proof for your pathology needs
The IVDR allows us to share our expertise with our customers, to reinforce the trust of our stakeholders, and to drive innovation forward, while maintaining the industry-leading quality standards that you are used to.
Class A Products
Ancillary reagents manufactured in-house such as wash buffers, detection systems, chromogenic products and instruments that fall under the class A category according to the regulation, —have been fully IVDR-compliant and available worldwide since May 26, 2022.
Class C Products
We obtained the first IVDR Certificate for our ZytoVision probes in 2024 and started the transition of the portfolio of 166 ISH Products. Already more than 70 of them are delivered in our distribution territories worldwide.
IVDR certification also grants market entry for new IVDs of the same type, enabling us to launch innovative diagnostic solutions already this year. These advances benefit patients and healthcare professionals and further solidify our competitive edge.
Current Status - What comes next?
After mastering the most important milestones also for our IHC portfolio, we invite you to discover how the rolling out process looks like.
IVDR-conform Production
Succesful Audit
Technical Documentation Approval
Certification Receival
Use of Stock
Relabelling
Roll-out
IVDR Portfolio Expansion
What does this mean for you?
Following our customer-first approach, we can assure you that all in vitro diagnostic products supplied to you always comply with the applicable requirements, so no action is required on your part.
Product names, order numbers and protocols remain the same, so there is no revalidations from your side required.
Due to the transitional period and associated deadlines, you can continue to use all our IVDD products for diagnostic purposes till the end of 2028.
By then, our clinical related product portfolio will be IVDR certified and you can continue uninterrupted your diagnostic routine.
We continuously invest in research and development to create innovative and high-quality products that meet the needs of our customers and the medical community. This certification enables us to regularly launch unique/new in-vitro diagnostic solutions for your needs in pathology.
If you have any questions or need support with overcoming challenges in your laboratory routine, please contact our scientific product management team.
Worth knowing - IVDR in a nutshell
The certification under the new 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).
What does the IVDR involve?
Introduction of a Unique Device Identifier for each IVD device leading to enhanced traceability and post-market surveillance
Accuracy and reliability in diagnostics: increased patient safety due to the high quality standards of the products
Risk classification of in vitro diagnostic medical devices
Involvement of notified bodies in conformity assessment procedures
Stricter requirements for clinical evidence and conformity assessment
You can view the full regulation here.
Thank you for your continued trust. We look forward to providing you with excellent products, solutions and systems for cancer diagnostics.
Stay tuned for continuous updates on the development of our IVDR product portfolio.
You can download our certificates here.
