IVDR Update
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. 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.
Milestones
We are one of the first companies implementing IVDR standards across our comprehensive product range. We invite you to learn more about our journey meeting all IVDR requirements.
Class A Products - ISH & IHC Products
Our Class A products (wash buffers, detection reagents, and chromogenic products) have been successfully implemented in the market in accordance with the IVDR since May 26, 2022.
Class C Products - ISH Product World
ZytoVision GmbH, a ZYTOMICS company, 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, you can find the Class C products that are already IVDR-labeled and meet the latest and strictest EU requirements here.
The IVDR certification allows the market entry of new IVDs of the same type. Therefore, our certification enables ZytoVision to launch again innovative diagnostic products, benefiting both patients and healthcare professionals as well as strengthening further our competitive advantage.
Class C Products - IHC Product World
Notified Body
Our path towards the IVDR certification is similar to the ISH product world, but is following a different and shifted time table.
Quality Management
Our dedicated task force is working at our locations in Germany, where CE-marked IVD products are produced, intensively to reach the given timeline. The team has completed a substantial volume of technical documentation, which was submitted to the notified body. Although Research Use Only (RUO) products do not have to meet the high requirements of IVDR, we would like to emphasize that we make almost no distinction between IVDs and RUOs in terms of our internal processes (e.g. same production processes and QC).
Product traceability and post-marketing surveillance
Our effective traceability system ensures that all our products and raw materials are identifiable and that we can respond to any request when needed / on demand. We continuously monitor the post-market performance of our products to ensure that they continue to meet the required standards and performance characteristics.
Product Design and Development
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.
We have mastered the important milestones as a manufacturer. The good cooperation with the notified body guarantees that all requirements for our products have been implemented and will lead to timely IVDR certification. We will always keep you up to date as part of our IVDR communication that you have enough time to validate any changes. You can also contact your local field representative.
Workshops & Webinars
We organize a series of professional educational activities, including workshops and webinars to support you in the IVDR transition process. Stay tuned for the upcoming events or contact us for more information under info@zytomics.com
Would you like to learn more? 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?
Stricter requirements for post-market surveillance and vigilance after placing on the market
Involvement of notified bodies in conformity assessment procedures
Stricter requirements for clinical evidence and conformity assessment
Introduction of a Unique Device Identifier for each IVD device
Risk classification of in vitro diagnostic medical devices
FAQs - ISH Product World and IVDR Certification
1. When will I receive an IVDR-labeled product? After certification, each new batch of a certified product is manufactured in accordance with the requirements of the IVDR, meaning the transition to the IVDR takes place at a different time for each product.
2. What do I have to do to obtain an IVDR-labeled product? Nothing. The changeover will take place automatically over time (see 1st question).
3. How will I be informed about the latest changes to the product status? Via our website, the instructions for use and labels of the products, the scientific field sales representatives and LinkedIn posts.
4. Do I have to change my SOPs? No. You can continue to work with our products exactly as before.
5. Do I have to dispose of my old IVDD product? No. IVDD products may continue to be used until the expiration date is reached.
6. Why is the IVDR important? The IVDR sets strict requirements for the quality, safety and performance of in vitro diagnostic medical devices. Due to the high-quality standards of the products used in medical diagnostics, patient safety is increased. Class C products must be converted by December 31, 2028.
Latest Update: October 2024