Declarations of conformity

With the EU declarations of conformity for our medical devices, we confirm compliance with the essential safety and performance requirements in accordance with Regulation (EU) 2017/745 on medical devices (Medical Device Regulation, MDR) and the relevant national provisions.

With the EU declarations of conformity for our in vitro diagnostic devices, we confirm either compliance with the essential requirements of Council Directive 98/79/EC on in vitro diagnostic medical devices (In-vitro Diagnostic Device Directive, IVDD) in conjunction with national regulations, or compliance with the essential safety and performance requirements in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In-vitro Diagnostic Regulation, IVDR) and the relevant national provisions.

Due to the applicable transition periods, Class As (A sterile) in vitro diagnostic medical devices may continue to be placed on the market as IVDD-certified products until 31 December 2029 at the latest, in accordance with IVDR-Art. 110.

The respective EU declaration of conformity clearly states the regulatory basis – IVDD or IVDR – on which the conformity assessment of the in vitro diagnostic medical device in question is based.

The EU declaration of conformity is a mandatory requirement for CE marking and the placing on the market of the respective product in the European Economic Area.