The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?

Speaker(s)

Melvin T1, Martelli N2, Kuhn S3, Tangila Kayembe O2, Michaelis I4, Peseke M4, McDonnell A5, Murphy F6, Geraghty M7, Banks H8, Callea G9, Tarricone R10
1Trinity College Dublin, Dublin, Leinster, Ireland, 2Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Pharmacy Department, Paris, Paris, France, 3Institute for Digital Medicine University Medical Center & Philipps-University, Marburg, Germany, 4Institute for Digital Medicine University Medical Center & Philipps-University, Marburg, Marburg, Germany, 5Trinity College Dublin, DUBLIN, Leinster, Ireland, 6Trinity College Dublin, Dublin , Ireland, 7Trinity College Dublin, Dublin, D, Ireland, 8SDA Bocconi School of Management, Milan, MI, Italy, 9SDA Bocconi School of Management, Milano, MI, Italy, 10SDA Bocconi School of Management, MILANO, MI, Italy

Presentation Documents

OBJECTIVES: As part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project, we analysed EU regulations, international standards, and guidelines to identify gaps that could affect a future EU EFS Program. We also conducted a specific analysis for digital health technologies (DHTs) that qualify as medical devices due to their unique lifecycles and features.

METHODS: A systematic review of the Medical Device Regulation 745/2017 (MDR), international standards from the International Standards Organisation (ISO), and guidelines for EFS and clinical investigations was conducted. To complement the regulatory and standards analysis, a comprehensive systematic literature review to identify international best practices was undertaken

RESULTS: The MDR covers clinical investigations generally rather than specifically addressing EFS requirements. We identified ISO standards relevant to EFS (n = 11), including those focused solely on clinical investigation design, and those with relatively detailed or minimal requirements for EFS. For DHTs, there is an absence of specific standards for clinical investigations and EFS. Regulatory guidance offers some relevant insights but does not conclusively address EFS studies. Pilot structures for advice under the MDR are currently in testing phases. Our analysis highlights the importance of iterative processes in EFS and stresses that early advice and ongoing engagement with competent authorities when undertaking these studies is essential

CONCLUSIONS: EFS are possible in the EU system but are not specifically facilitated. Additionally, available guidance, standards, and templates do not address EFS-specific considerations. DHTs have unique conceptual characteristics, with a focus on validation, and the results of an EFS for these technologies can sometimes be used to achieve both market access (CE marking) and provisional reimbursement in certain EU Member States.

Code

HPR98

Topic

Medical Technologies, Study Approaches

Topic Subcategory

Literature Review & Synthesis, Medical Devices

Disease

Medical Devices