IVDR 2017/746 came into force on May 25, 2017, and has been binding since May 26, 2022. At the same time, the MPG was replaced by the MPDG for the IVDD on May 26, 2022. The amendment proposal submitted by the EU Commission on October 14, 2021, for IVDR 2017/746 specified deadline changes with transitional provisions for products that were already legally placed on the market before the date of application. These transitional provisions affect our test kits and controls, which are classified as Class B according to IVDR 2017/746. The transition period for these products ends on December 31, 2029.

The transitional provisions pursuant to Article 110 of IVDR 2017/746 refer to products classified as “Other” under the IVDD and Directive 98/79/EC. All our products are existing products. This means that even after the IVDR 2017 expires on May 26, 2022, they may continue to be placed on the market until December 31, 2029, provided that they comply with the requirements of the IVDD and no significant changes are made to their design or intended purpose. This requirement is met for our test kits and controls.

Our photometers are Class A products, which are not subject to the transition period. They are certified in accordance with IVDR 2017/74