The IVDR Regulation
Dear Valued Customers
In line with the EU Regulation on medical devices, the EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) entered into force on May the 26th, 2017. As of May the 26th, 2022 on the territory of the European Union, all in vitro medical devices will have to meet the requirements of the IVDR in order to be placed in the European market. The IVDR will replace the EU's current Directive on in vitro diagnostic medical devices (98/79/EC). Under the IVDR, all manufacturers with currently approved in vitro diagnostic devices have to demonstrate compliance with the IVDR's new requirements.
In Cormay we are obliged to actively and timely manage the transition from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR). As a result, all Cormay and Orphée product categories will get (re-)certification in compliance with the new regulation. We are committed to managing this important transformation in the least troublesome way for our customers without any disruptions to your business. Meeting the regulatory requirements and maintaining the comprehensiveness of the offer is our top priority.
Please stay tuned for further communications on this topic over the coming months. We thank you in advance for your understanding and cooperation.
More information about the IVDR: https://ec.europa.eu/health/md_sector/overview_en