MDSAP Updates Audit Approach Document with Expanded Process-Based Guidance
The updated MDSAP Audit Approach document, MDSAP AU P0002.011, provides detailed instructions for conducting process-based MDSAP audits and integrates the former Audit Model and Process Companion documents.
NIST Publishes Generative AI Profile for the AI Risk Management Framework
NIST AI 600-1 provides a Generative AI Profile for the AI Risk Management Framework, identifying key GAI risks and suggested actions to govern, map, measure and manage them.
Team-NB Calls for Broader EUDAMED Transparency to Support Risk-Adaptive Surveillance
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.
Team-NB Highlights Risk-Adaptive Surveillance under the MDR and IVDR
Team-NB has presented a proposal for risk-adaptive notified body surveillance under the MDR and IVDR, aiming to reduce unnecessary burden while maintaining patient safety and effective oversight.
ISO Publishes ISO 14155:2026 on Good Clinical Practice for Medical Device Clinical Investigations
ISO 14155:2026 specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices involving human subjects.
MHRA Issues 5th Edition Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use
MHRA releases the 5th edition of its Safety Guidelines for Clinical MRI Equipment, updating governance, ASTM F2503-26 standards, RF burns, and implant rules.
ICH Publishes Updated Support Package for ICH M8 eCTD v4.0
ICH M8 Working Group updates eCTD v4.0 support materials, including the Implementation Guide, Controlled Vocabularies, and Q&A documentation.
FDA Announces Opening of FY2027 MDUFA Small Business Determination Window
FDA opens the FY2027 MDUFA Small Business Request window on August 1, 2026. Learn eligibility rules, user fee discounts, and submission steps.
FDA Updates Authorized Companion Diagnostic Devices List to 226 Entries
FDA updates its list of authorized companion diagnostic devices to 226 entries, covering NGS assays, liquid biopsies, group labeling, and key biomarkers.
MHRA Releases AI Airlock Sandbox Phase 2 Programme Report
MHRA releases its AI Airlock Sandbox Phase 2 report, detailing regulatory insights on AI validation, PCCPs, generative AI, and real-world PMS.
2026 MDSAP Forum Outcome Statement Highlights Global Expansion and EU Alignment
The MDSAP Regulatory Authority Council releases the 2026 Forum Outcome Statement, detailing 2025 performance, MDO pilot results, and EU MDR alignment.
FDA Issues Guidance on Cancer Clinical Trial Eligibility: Laboratory Values
FDA issues guidance on cancer clinical trial eligibility, recommending evidence-based laboratory criteria to reduce unnecessary exclusions in oncology studies.
Team-NB Updates Consensus Position Paper on the MDR Certification Process
Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.
EU Publishes Regulation (EU) 2026/1744: The Digital Omnibus on Artificial Intelligence
European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.
FDA Issues Guidance on Cancer Clinical Trial Eligibility: Performance Status
FDA issues new guidance on cancer clinical trial eligibility, recommending broader inclusion of patients with ECOG PS2 and KPS 60–70 performance status.
FDA Issues Guidance on Cancer Clinical Trial Eligibility: Washout Periods and Concomitant Medications
Discover the new FDA guidance on oncology trial eligibility criteria, risk-based washout periods, and concomitant medication management for clinical studies.
MHRA Updates Guidance on Clinical Investigations for Medical Devices
The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.
MHRA Updates Guidance on Determining Whether a Clinical Investigation Is Required
The MHRA has updated its guidance on determining whether a clinical investigation is required for medical devices in Great Britain, covering pre-clinical testing, PMCF, medical purpose, research tools and notification requirements.
European Commission Renews UDI Issuing Entity Designations Until 2029
Commission Implementing Decision (EU) 2024/2120 renews the designation of UDI issuing entities for medical devices and IVDs for a further five-year period, until 27 June 2029.
FDA Issues Draft Guidance on Biocompatibility Testing Under the ASCA Program
FDA has issued draft guidance on biocompatibility testing of medical devices under the ASCA Program, covering recognized standards, laboratory accreditation, test methods and premarket submission content.