News EU “Digital Omnibus on AI”: European Parliament amendments adopted on 26 March 2026 Read More » New ISO update for medical devices: ISO 14155:2026 (Edition 4) Read More » MDCG 2025-8 Rev. 1: Guidance on Master UDI-DI implementation for spectacles-related HIDs Read More » EU MDR: Delegated act expands list of implantable & Class III devices that may be exempt from clinical investigations Read More » 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 » Page1 Page2 Page3 Page4 Page5
EU MDR: Delegated act expands list of implantable & Class III devices that may be exempt from clinical investigations Read More »
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 »
