Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period will end on 26 May 2022, the “Date of Application” (DoA) of the Regulation. To avoid market disruption and allow a smooth transition from the Directive to the Regulation, several transitional provisions are in place (Article 110). Under certain conditions, in vitro diagnostic devices with valid certificates issued under the Directive may continue to be placed on the market until 27 May 2024 and made available until 27 May 2025 (Article 110 paragraph 4).
European Commission prepared the following EU IVDR Factsheet and FAQ:
ARQon EU IVDR Book:
ARQon Medtech Europe GmbH, is in the progress of preparing for the EU IVDR Book. We target readiness in the year 2020.
Source: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations_en
Contact us at info@arqon.com.