Callea, G.; Federici, C.; Freddi, R.; Tarricone, R. Recommendations for the Design and Implementation of an Early Feasibility Studies Program for Medical Devices in the European Union. Expert Rev Med Devices2022, 1–11.

This paper explores the characteristics of EFS, focusing on the studies conducted under the US FDA EFS program, started in 2013, but with implications for similar studies in Europe made possible by the International Standard ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice and provisions in the EU Medical Devices Regulation, effective since 2021. The perceptions and opinions of an expert, multidisciplinary panel of key stakeholders (clinical investigators, biomedical engineers, academics, members of scientific and professional associations, members of ethics committees, developers of new technologies) were also collected regarding the need for an ad hoc EFS program in the EU to provide a standardized procedural framework these types of pre-market studies. Findings indicate a favorable environment for an EFS program in the EU, with process, resources and ethical issues indicated as determinant factors for its effective design and implementation.

Tarricone, R.; Ciani, O.; Torbica, A.; Brouwer, W.; Chaloutsos, G.; Drummond, M. F.; Martelli, N.; Persson, U.; Leidl, R.; Levin, L.; Sampietro-Colom, L.; Taylor, R. S. Lifecycle Evidence Requirements for High-Risk Implantable Medical Devices: A European Perspective. Expert Review of Medical Devices2020, 17 (10), 993–1006.

The paper summarizes findings from an expert discussion group and supporting literature in addressing two broad research questions:

  1. What is the appropriate level (in terms of type, quantity, quality) and timing of evidence that is sufficient to satisfy value assessors and payers needs throughout the lifecycle of lifesaving implantable medical devices (MDs)?
  2. How could the evidence generation ecosystem be adapted to optimize patient access vis-à-vis risks for patients, healthcare providers, payers and technology developers?

Focused on high-risk, implantable MDs, the paper provides a review of the European regulatory and HTA environments for MDs, with reference to global regulatory environments, and outlines, describes and critically discusses clinical evidence generation needs throughout the lifecycle of MDs, divided into four relevant stages: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market.

Tarricone, R.; Banks, H.; Ciani, O.; Brouwer, W.; Drummond, M. F.; Leidl, R.; Martelli, N.; Sampietro-Colom, L.; Taylor, R. S. An Accelerated Access Pathway for Innovative High-Risk Medical Devices under the New European Union Medical Devices and Health Technology Assessment Regulations? Analysis and Recommendations. Expert Review of Medical Devices2023, 0 (0), 1–13.

This perspective article presents relevant literature and expert opinion to explore the need for an accelerated access program for medical devices in the European Union, that would combine elements of accelerated approval programs observed in other jurisdictions with post-approval evidence generation and monitoring needed for HTA, pricing and reimbursement. Leveraging learnings from accelerated approval programs worldwide, ties between the two new EU regulations, and provisions in the regulations for expert panel advice and increased stakeholder involvement, the recommendations cover various stages from the approval process through coverage and clinical uptake in the lifecycle of MDs, with the goal to safely speed patient access to innovative, life-saving technologies and increase collaboration among Member States on coverage decisions.