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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

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

SWITZERLAND | swissdamed UDI Module Goes Live — Mandatory Device Registration from July 2026

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SWITZERLAND | swissdamed UDI Module Goes Live — Mandatory Device Registration from July 20262025-09-11T07:10:49+00:00

AUSTRALIA | TGA Mandates Hospital Reporting & UDI System — Implications for Device-Based Real-World Research

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AUSTRALIA | TGA Mandates Hospital Reporting & UDI System — Implications for Device-Based Real-World Research2025-09-10T10:22:01+00:00

UK | MHRA Retains Critical Medical Device Regulations Following Overwhelming Industry Support

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UK | MHRA Retains Critical Medical Device Regulations Following Overwhelming Industry Support2025-08-02T11:12:25+00:00

EU | Medical Device Authorities Call for Centralised Regulatory Reform to Address System Fragmentation

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EU | Medical Device Authorities Call for Centralised Regulatory Reform to Address System Fragmentation2025-08-02T10:51:58+00:00
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