- USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics Gallery
USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics
2025, December 2025, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics
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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices
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ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines
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UK | MHRA Signals Major Change for Rare Disease Treatments
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UK | HRA Describes Phased Approach to Implementing New Research Systems Platform (IRAS Replacement)
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CHINA | Significant Revisions to the Cybersecurity Law
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SPAIN | Royal Decree 942/2025 on In-Vitro Diagnostic Medical Devices – Implications for PMPF Studies
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INDIA | Digital Personal Data Protection (DPDP) Rules 2025 – Implications for Real-World Research
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- EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research Gallery
EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
2025, AI, Cvbersecurity, Data Privacy and Data Protection, EHDS, EU, Expert Insights, Members-Only, Minor Update, October 2025
EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
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