The IVDR 2017/746 came into force on 25 May 2017 and has been binding since 26 May 2022. At the same time, the MPG was replaced by the MPDG for the IVDD on 26 May 2022. The amendment proposal submitted by the EU Commission on 14 October 2021 for IVDR 2017/746 stipulated changes to deadlines with transitional provisions for products that were already legally placed on the market before the date of application.

These transitional provisions affect all our products. The transitional period for our products, which are all classified as Class B in accordance with IVDR 2017/746, ends on 25 May 2027. The transitional provisions in accordance with Article 110 of IVDR 2017/746 are taken into account in our quality management with regard to our products that were classified as “Others” in accordance with the IVDD and Directive 98/79/EC.

All our products are legacy products. This means that they could continue to be placed on the market after the IVDR 2017 expiry date of 26 May 2022, provided that they comply with the requirements of the IVDD and no significant changes are made to the design and intended use. This requirement has been fulfilled for all our products.