In Vitro Diagnostic Medical Devices Regulation
In May 2017, the European Union published the In Vitro Diagnostic Medical Devices Regulation EU 2017/746 (IVDR) which repeals the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) in order to establish a more robust, transparent, predictable and suitable regulatory framework for IVD Medical Devices.
Cytognos and the new IVD Regulation
Cytognos offers extensively validated panels. In order to guarantee the quality and the availability of our products, we are working hard to continue offering our diagnostic kits, antibodies, Infinicyt™ and Omnicyt™ under the IVDR (the end of the transition period to implement the new Regulation is on May 26th, 2022).
If the transition period does not allow us to have any of the above products on the market as CE-IVD (under the new Regulation by the specified date), then we will follow the indications established in the Article 110 (4) of the IVDR. This means that these products will be available as CE-IVD until May 27th 2025 or the expiration date, whatever occurs first, until an IVDR certificate is issued.