The TGA has opened a consultation on proposals to improve public information sharing about the safety, quality and performance of medical devices after post-market reviews or investigations.

Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.

Team-NB has highlighted the need for broader notified body access to EUDAMED vigilance, clinical investigation and performance study data to support proportionate risk-adaptive surveillance under the MDR and IVDR.

The EU HTA Coordination Group has adopted new guiding principles on data transparency, clarifying confidentiality expectations for Joint Clinical Assessments involving medical devices and IVDs.