DiaMetra is committed to managing the important transition from the EU In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR), thereby ensuring our key products are available to healthcare professionals around the world, whilst ensuring a high level of quality and safety for patients and users.
As part of this commitment, DiaMetra has received certification from our Notified Body (TÜV Rheinland) that their conformity assessment of our devices according to new EU IVDR regulation was completed and our ELISA products are compliant with IVDR requirements. This certification allows the release of several CE marked IVDR Class B reagents in compliance with the IVDR regulations.
Following this certification, DiaMetra is working on a transition plan to allow a phased release of 34 certified products which will begin in December 2025.
DiaMetra Srl. strive to provide products of the highest quality. We value your business and thank you for your continued support. Please contact your local DiaMetra representative if you have any questions regarding this information.