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

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

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

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

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

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
Tasks
More information coming soon
More information coming soon
More information coming soon
More information coming soon
More information coming soon