IVDR Update October 2022
As a manufacturer and distributor of in vitro diagnostics, our enterprise group with the companies Zytomed Systems GmbH and ZytoVision GmbH attaches great importance to the timely implementation of the requirements of the IVDR (Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5th 2017 on in vitro diagnostic medical devices).
ZytoVision GmbH was founded in 2004 and plays a leading role in the clinical pathology market as a manufacturer of in vitro diagnostic products in the form of in situ hybridization probes for FISH and CISH as well as VisionArray® chips for pathogen diagnostics. Since 2006, ZytoVision GmbH has been working under a certified quality management system in accordance with the standards ISO 9001:2015 and ISO 13485:2016. Last year, ZytoVision GmbH was able to conclude a contract with DEKRA as a notified body for conformity testing according to IVDR and successfully passed phase 1 and phase 2 audits in spring 2022. The declarations of conformity for reagents of risk class A as well as the registration as a manufacturer in the EUDAMED database (European Database on Medical Devices) also took place on schedule. As the third component for the approval of IVDR-compliant in vitro diagnostic medical devices of class C, the technical documentation is currently being reviewed by DEKRA. We will inform you as soon as our products for in vitro diagnostics are CE/IVD compliant under the new EU regulation 2017/746.
Zytomed Systems GmbH, manufacturer and distributor of CE/IVD-certified antibodies, detection systems, and in situ hybridization tests since 2005, and by now additionally of DNA chips for pathogen diagnostics, as well as qPCR tests and NGS kits for mutation analyses, has also been implementing the ISO 9001:2015 and ISO 13485:2016 standards in its quality management system for some time. On time before the deadline on May 26th 2022, the conformity of risk class A reagents to the IVDR was declared. Zytomed Systems GmbH is also a registered manufacturer in the European EUDAMED database. Like ZytoVision GmbH, Zytomed Systems GmbH has submitted all necessary documents to DEKRA as a notified body to start the testing process for the certification of class C in vitro diagnostic medical devices. As soon as possible, but no later than May 26th 2026, we will serve you with our class C products in the usual quality and CE/IVD-compliant according to IVDR.
Phases of IVDR implementation for us as a manufacturer:
Certification of the quality management system according to ISO 9001:2015 and ISO 13485:2016
Contract with a notified body (e.g. DEKRA) for an audit in accordance with the IVDR regulation (EU 2017/746)
Phase 1 audit by the notified body: examination of the processes required by the IVDR (e.g. post market surveillance)
Phase 2 audit by the notified body: examination of the implementation of the processes required by the IVDR (e.g. records)
Registration as a manufacturer of in vitro diagnostic medical devices in the EUDAMED (European Database on Medical Devices) database
Declaration of conformity of class A products according to IVDR (2017/746) by the manufacturer
Examination of the technical documentation for class C devices by the notified body
After receipt of the IVDR certificate by the notified body: Declaration of conformity of class C products according to IVDR (2017/746) by the manufacturer
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