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
New high-risk implantable medical devices undergo frequent iterative changes during their early development, and early feasibility studies inevitably carry some risk of unexpected events.
Many devices that are now fully established in routine practice had risks during their implementation that would later be considered unacceptable. In this regard, an Ethics charter is needed to advise on ethical standards and practice for innovators, clinical researchers, manufacturers, and be useful for all stakeholders, including patients, ethics committees, and regulators. This charter is based on work undertaken in other work packages (2.1 and 2.4) and will be worked out in the second phase of the project.
This task aims at approving CORE–MD proposals for a hierarchy (or perhaps a matrix) of levels of clinical evidence for high-risk medical devices. It also aims 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. It will start in the second phase of the project.
The aim of Task 4.3 is to identify the needs for advanced training for the assessment of high-risk MD, in the context of the EU MDR. AIHTA, Team-NB, BioMed Alliance and ESC held regular meetings to discuss the progress of this task. A landscape of available advanced trainings, qualifications on MD Regulation (MDR) as well as an overview on competences in regulatory science mentioned in publications was performed.
The CORE-MD survey, developed in the EU survey tool, included around 25 questions and asked about perceived needs for training in regulatory affairs/sciences, core methodological competencies as well as the view on training formats and modalities. In total 409 responses to the CORE-MD survey were received. Results were analysed and are presented in a roadmap.
The dissemination and communication plan (D.4.6) has been elaborated. It detailed the three phases of the CORE-MD project namely:
– General promotion and strategy making (M1-M6)
– Dissemination and communication activities (M7-M30)
– Finalisation (M31-M36)
Each partner has contributes to the dissemination of CORE-MD’s outputs either at the level of its institutions or EU-wide in the framework of annual scientific congresses. Thanks to the existing network of CORE-MD partners, and the active support of the European Commission, CORE-MD is being actively promoted at the European level.
This task has taken care to setup the relevant tools and infrastructure to support a highquality communication. Namely, the brand identity of the project and the website have been designed and setup. Templates, logos and social media channels have been created. Also, newsletter have been used as effective mean for communication.
