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UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers

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UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers2026-06-12T11:30:22+00:00

EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate

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EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate2026-06-12T11:07:33+00:00

UK | MHRA Draft 2026 Medical Device Regulations — International Reliance, UDI and Lifecycle Traceability Move Into Draft Legislative Form

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UK | MHRA Draft 2026 Medical Device Regulations — International Reliance, UDI and Lifecycle Traceability Move Into Draft Legislative Form2026-06-12T10:22:11+00:00

Canada | Health Canada Expands Lifecycle Oversight of Medical Devices Through New Guidance Framework

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Canada | Health Canada Expands Lifecycle Oversight of Medical Devices Through New Guidance Framework2026-05-14T13:53:45+00:00

USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making

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USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making2026-04-12T13:13:11+00:00

AUSTRALIA | TGA Publishes Guidance on Regulation and Post-Market Responsibilities for Software-Based Medical Devices

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AUSTRALIA | TGA Publishes Guidance on Regulation and Post-Market Responsibilities for Software-Based Medical Devices2026-03-10T11:39:03+00:00

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
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