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Università Commerciale Luigi Bocconi

L'Università Bocconi fondata a Milano nel 1902, come università privata, indipendente, non -profit diventa la prima istituzione di istruzione superiore Italiana a fornire un titolo di laurea in Economia.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

The IHI project HEU-EFS aims to establish a harmonised approach to Early Feasibility Studies (EFS) for medical devices in the European Union. ISO 14155:2020 defines EFS as limited clinical investigations which aim to evaluate the initial clinical safety and performance of a device. Conducted at an early stage before the device has been finalised, EFS can collect critical information on device design, safety, functionality, and/or performance, particularly when nonclinical testing is either not feasible or not sufficiently informative. They are important in the evidence generation pathway for their potential to enhance earlier patient access to safe and innovative devices, helping to boost the EUs clinical excellence and innovation investment attractiveness. Although not excluded under the current EU MDR, there is presently no harmonised approach with a specific pathway that facilitates EFS adoption. Currently, EFS assessment across NCAs is divergent. In view of the targeted MDR reform, HEU-EFS welcomes the opportunity to provide recommendations to simplify, optimise and prioritise timely patient access and innovation. Based on research and analysis as well as stakeholder interviews, HEU-EFS makes 4 recommendations for the MDR reform: Introduce a specific definition of EFS aligned with international practice to differentiate these studies from other confirmatory investigations. HEU-EFS suggests that EFS would be intended mainly for high-risk devices (which could include certain Digital Health Technologies), especially those that address unmet medical needs, represent breakthrough innovations, or aim to improve anatomical and physiological device solutions. Additionally, EFS would be applicable for devices with new or expanded intended use or indications for use, for which clinical investigations are needed to support a future conformity assessment. Foster early dialogue with key stakeholders as part of the decision-making process: The MDR could explicitly describe early dialogue to support a harmonized, non-binding framework for guidance and advice, bringing together institutional stakeholders involved (NCAs, sponsors, and clinical sites/ investigators), potentially including ethics committees and the expert panels where appropriate. Introduce the concept of as far as possible for EFS: Given the specific nature of EFS, allowing for certain non-clinical/pre-clinical testing to be performed in parallel or immediately subsequent to an EFS, when this does not impact on the overall safety of the study (for example shelf-life or packaging testing), but before confirmatory clinical investigations would allow for more predictability in the regulatory requirements for all stakeholders. Establish a dedicated EFS process supported by EFS-specific templates and checklists to streamline and accelerate application and review. Building on early dialogue, the use of EFS tools (informed consent form, clinical investigation protocol, insurance agreement checklists, dedicated patient involvement roadmap), could accelerate and facilitate efficiency in planning, submission and monitoring. In the dedicated process, a parallel review of ethics committee and NCA could be explored. The value of EFS for MDAI should be recognized to support the introduction of these technologies. In addition to the dedicated focus on EFS in the MDCG Guidance, articles to be considered for amendment in the MDR reform to foster EFS adoption could include Articles 62, 75, and 82, and Annex XV, thereby explicitly recognising the phases of exploratory (EFS), confirmatory (Pivotal), and post-market (PMS) investigations within the MDR. Such amendments could highlight the concise and specific nature of EFS, the need for dedicated processes, and their inherent need for modifications during the study. This would further clarify the clinical evidence development pathway, support harmonisation, and strengthen predictability for all institutional actors.
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Meeting with Alexandra Jour-Schroeder (Deputy Director-General Financial Stability, Financial Services and Capital Markets Union) and Katholieke Universiteit te Leuven

2 Oct 2025 · European Capital Markets Law Project

Meeting with Marc Lemaitre (Director-General Research and Innovation)

3 Jul 2025 · discussion on the new IEP@BU report and on the EU innovation policy can support the competitiveness of the EU economy in general.