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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices

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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices2026-01-09T12:42:07+00:00

ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines

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ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines2026-01-09T12:36:06+00:00

UK | HRA Describes Phased Approach to Implementing New Research Systems Platform (IRAS Replacement)

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UK | HRA Describes Phased Approach to Implementing New Research Systems Platform (IRAS Replacement)2025-12-07T15:38:34+00:00

SPAIN | Royal Decree 942/2025 on In-Vitro Diagnostic Medical Devices – Implications for PMPF Studies

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SPAIN | Royal Decree 942/2025 on In-Vitro Diagnostic Medical Devices – Implications for PMPF Studies2025-12-07T15:43:32+00:00

INDIA | Digital Personal Data Protection (DPDP) Rules 2025 – Implications for Real-World Research

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INDIA | Digital Personal Data Protection (DPDP) Rules 2025 – Implications for Real-World Research2025-12-07T15:20:36+00:00

EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and 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 Research2025-11-09T10:51:38+00:00

EU | TEHDAS2 Opens Public Consultation on Health Data Access Guidelines — Paving the Way for EHDS Implementation

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EU | TEHDAS2 Opens Public Consultation on Health Data Access Guidelines — Paving the Way for EHDS Implementation2025-11-09T10:19:16+00:00
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