National Competent Authorities’ Experiences With Early Feasibility Study Assessment: Promoting Dialogue, Supporting Sponsors, and Fostering Shared Learning to Harmonize the EU Framework
Author(s)
Federico Facciolo, MS, PhD1, Franco Luigi Zurlo, MSc1, Giuditta Callea, PhD1, Alexandra H.C. Poulsson, PhD2, Tom Melvin, LLB, LLM, MBBS3, Francesco Benito Malandrini, PharmD1, Niccolò Palminteri, MSc1, Majella Geraghty, PhD3, Marit Erna Austeng, PhD2, Maria Luisa Buzelli, BS1, Helen Banks, BA, MA1, CARLO FEDERICI, MSc, PhD1.
1SDA Bocconi School of Management, Milano, Italy, 2Norwegian Institute of Public Health, Oslo, Norway, 3University of Galway, Galway, Ireland.
1SDA Bocconi School of Management, Milano, Italy, 2Norwegian Institute of Public Health, Oslo, Norway, 3University of Galway, Galway, Ireland.
OBJECTIVES: Early Feasibility Studies (EFS) are small, early-phase clinical investigations conducted to establish proof of concept and refine device design when further preclinical testing is uninformative or unavailable. A harmonized procedural framework for EFS is lacking in the EU. As part of the Harmonised Approach to EFS for Medical Devices in the EU (HEU-EFS) project, this study explored the experiences of National Competent Authorities (NCAs) during EFS assessments to identify processes, stakeholder roles, and timelines that could inform such framework.
METHODS: Four online focus groups were conducted with representatives from four NCAs, involving two participants per session (n=8). Each country participated in a separate session. Topics included experiences with EFS, dialogue with sponsors, and harmonisation and efficiency of EFS assessment. Focus groups lasted 90 minutes and recorded and transcribed via Microsoft Teams. Data were analysed using thematic analysis using deductive coding based on interview topics and questions.
RESULTS: Five main themes emerged from the focus groups: (1) Lack of formal EFS definition in EU regulation results in disparate EFS assessments across NCAs, (2) Poor EFS documentation quality and limited evidence on novel technologies challenge NCAs’ validation and evaluation of EFS, (3) Dialogue improves EFS assessment efficiency and speed through NCA adaptability and sponsor cooperation, (4) Shared learning and collaboration in the Coordinated Assessment pilot under the MDR represent a starting point to developing a harmonized EFS guidance and ensuring a unified assessment approach in the EU, and (5) Following up with sponsors for additional data and providing standardized templates facilitate NCAs’ timely evaluations when key information is missing from EFS applications.
CONCLUSIONS: NCAs reported a lack of a harmonised approach to EFS, where adaptable dialogue with sponsors was perceived to improve assessments. Promoting dialogue with sponsors, supporting their preparedness, and encouraging shared learning among NCAs are essential to inform a harmonised EU EFS framework.
METHODS: Four online focus groups were conducted with representatives from four NCAs, involving two participants per session (n=8). Each country participated in a separate session. Topics included experiences with EFS, dialogue with sponsors, and harmonisation and efficiency of EFS assessment. Focus groups lasted 90 minutes and recorded and transcribed via Microsoft Teams. Data were analysed using thematic analysis using deductive coding based on interview topics and questions.
RESULTS: Five main themes emerged from the focus groups: (1) Lack of formal EFS definition in EU regulation results in disparate EFS assessments across NCAs, (2) Poor EFS documentation quality and limited evidence on novel technologies challenge NCAs’ validation and evaluation of EFS, (3) Dialogue improves EFS assessment efficiency and speed through NCA adaptability and sponsor cooperation, (4) Shared learning and collaboration in the Coordinated Assessment pilot under the MDR represent a starting point to developing a harmonized EFS guidance and ensuring a unified assessment approach in the EU, and (5) Following up with sponsors for additional data and providing standardized templates facilitate NCAs’ timely evaluations when key information is missing from EFS applications.
CONCLUSIONS: NCAs reported a lack of a harmonised approach to EFS, where adaptable dialogue with sponsors was perceived to improve assessments. Promoting dialogue with sponsors, supporting their preparedness, and encouraging shared learning among NCAs are essential to inform a harmonised EU EFS framework.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MT31
Topic
Health Policy & Regulatory, Medical Technologies, Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas