IVDR Update

We have recently updated the “Certified Quality” section on our website. You can now find comprehensive information about the current status of our IVDR compliance. The implementation of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) is a key element of our quality and regulatory strategy. As a manufacturer of diagnostic products, we are committed not only to meeting regulatory requirements but to exceeding them through transparency and diligence. The updated section now includes:

• a clear overview of our progress in product certification
• information material on transition periods and more (FAQs), available for download
• and our valid certificates and notifications from our Notified Bodies.

With this update, we aim to provide our customers, partners, and stakeholders with transparent and up-to-date insights into our quality assurance efforts and regulatory compliance.

Learn more about our certified quality