EU | New Guidance on Clinical Evaluation of Orphan Medical Devices (MDCG 2024-10)
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EU | MDCG Guidance on Content of Clinical Investigation Plans for Medical Devices
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USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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UK | 4 New Medical Device Statutory Instruments to be Implemented in 2024
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UK | Implementation of the Future Medical Device Regulations
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EU | New Commission Implementing Regulation (EU) 2023/1194 on Transitional Provisions for Products without an Intended Medical Purpose
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EU | Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report
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UK | Artificial Intelligence and Digital Regulations Service Launches
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Spain | New Medical Device Royal Decree
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