Understanding Europe's IVDR скачать в хорошем качестве

Understanding Europe's IVDR

The new Europe In Vitro Diagnostic Medical Device Regulation (IVDR) is on the horizon. While the 2022 deadline may seem distant, manufacturers need to start taking steps now to achieve compliance. The increased number of modifications, definitions, classifications, and conformity assessments will involve careful evaluation and process revisions. Significant requirements for clinical evidence will also be enforced, with an increased focus on intended use and user environment. Most notably, individual trials for each unique product will be required, with a user environment relative to laboratory, near-patient testing (NPT) and self-testing.