Understanding MDCG 2023-7 - Exemptions from Clinical Investigations for Medical Devices
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2024-6-4 16:36
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Dive into the latest guidance with MDCG 2023-7: Unveiling key exemptions from clinical investigations for medical devices and mastering the art of demonstrating equivalence. This essential overview highlights the critical pathways for implantable and class III devices within the EU market, pinpointing when clinical trials can be bypassed under specific conditions. Learn about the strategic importance of having 'sufficient levels of access' to data, ensuring your medical innovations meet regulatory standards without compromising on safety. Perfect for manufacturers aiming to navigate the complexities of the regulatory environment efficiently.
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