Project Lead(s): Rosanna Peeling
The second phase of the initial project (0056-02) is to develop and pilot a streamlined and harmonized regulatory process for the approval of a point-of-care (POC) IVD. We will combine scientific, technological, social and business innovations to seed regulatory reform. We will work with regional harmonization working parties as implementing partners to focus on four potential areas of harmonization: 1) a Standard Technical Document (STED) for registration of POC IVDs; 2) convergence of standards for quality audits of POC IVD manufacturing sites: 3) a mechanism to reduce duplication in clinical trials for validating the performance of a POC IVD; 4) a system for post-marketing surveillance. The project will deliver a set of harmonized regulatory standards and project outcomes will be disseminated for adoption by regions and countries.