BioSystems IVDR

Getting ready for the In Vitro Diagnostic Regulation

BioSystems ©2024

The IVD Regulation replaces the European Directive IVDD (Directive 98/79/EC) for IVD devices, with the aim of ensuring a high level of protection of public health, patients, and users.

More rigorous analytical and clinical performance studies.

What’s new for users? New packaging labeling & IFU update; Eudamed database: more transparency and traceability; Closed validated analytical solutions focus only on results quality.

Download the technical sheet. If you can not find what you are looking do not hesitate to reach us and we will be happy to help.