News Final guidance on using Real-World Evidence (RWE) to support medical device regulatory decision-making Read More » FDA guidance (Dec 2025): Processes and practices for Bioresearch Monitoring (BIMO) inspections Read More » MDCG 2025-10: Guidance on post-market surveillance (PMS) for medical devices and IVDs Read More » EU draft rules on Annex VII: mandatory timelines for MDR/IVDR conformity assessment — Team-NB’s key recommendations Read More » FDA Guidance: How to Prepare a Pre-Request for Designation (Pre-RFD) Read More » MedTech Europe Advocates for a Risk-Based Approach to PMCF under the MDR Read More » TEAM-NB Issues Updated Position Paper on IVDR Annex IX Changes to Companion Diagnostic Devices Read More » TEAM-NB & NBCG-Med: Call for Evidence on Digital Omnibus – Simplifying AI Regulation with Clarity and Sustainability Read More » FDA’s New Guidance on IVD Enforcement Policies During Declared Emergencies: A Strategic Shift for Diagnostic Developers Read More » Page1 Page2 Page3 Page4 Page5
Final guidance on using Real-World Evidence (RWE) to support medical device regulatory decision-making Read More »
FDA guidance (Dec 2025): Processes and practices for Bioresearch Monitoring (BIMO) inspections Read More »
EU draft rules on Annex VII: mandatory timelines for MDR/IVDR conformity assessment — Team-NB’s key recommendations Read More »
TEAM-NB Issues Updated Position Paper on IVDR Annex IX Changes to Companion Diagnostic Devices Read More »
TEAM-NB & NBCG-Med: Call for Evidence on Digital Omnibus – Simplifying AI Regulation with Clarity and Sustainability Read More »
FDA’s New Guidance on IVD Enforcement Policies During Declared Emergencies: A Strategic Shift for Diagnostic Developers Read More »
