Work Package 4 will provide the forum for all stakeholders to exchange best practices and collectively review the evidence generated, adopt position papers and recommendations.

Objectives

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To develop a charter for ethical practice related to clinical investigations of innovative high-risk medical devices

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To approve CORE–MD proposals for a hierarchy of levels of clinical evidence for high-risk medical devices

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To recommend how EU regulatory systems can implement new methodologies for clinical investigations of high-risk medical devices, using evidence generated across their whole life cycle

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To identify the training needs of all stakeholders to enhance their expertise in methodologies for the assessment of high-risk medical devices, and develop appropriate educational objectives

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To disseminate the publications, educational resources, and outcomes of CORE-MD as widely as possible to the clinical community and all stakeholders through newsletters, webinars, and social media