Capacity building in the medical device regulatory inspectorate

Abstract

Introduction: Harmonised inspections strategies of medical device economic operators are considered as one of the arms of market surveillance activities within the 2017 medical device regulations (EU MOR 2017/745), that enhance the use of safe medical devices on the European market. Cooperation between regulatory bodies and business market is essential to ensure utmost clarity and effectivity in regulation interpretation. Communication is strengthened through inspections of economic operators. Inspectors' capacity can be enhanced through training, resource usage, technical help, assessment, feedback and collaboration. Key competencies for regulatory inspectors can be categorised as (i) regulatory knowledge and technical expertise, (ii) inspection skills and (iii) ethical and professional conduct. The aim was to establish a capacity-building framework for medical device regulatory inspectors within European National Competent Authorities (EU NCAs), presented as a structured guidance document. This initiative focuses on enhancing inspector competencies to ensure robust regulatory surveillance of medical devices. Method: A validated questionnaire was disseminated to medical device regulatory inspectors across EU NCAs to gather information on the framework implemented, including number and type of inspections carried out, expertise available and training plan of inspectors. The questionnaire included multiple choice, close and open ended questions. Respondents were requested to rate using a 5-point likert scale the challenges faced by t he respective NCA and the areas for which inspectors require further 9 FIP Copenhagen conference abstracts 2025 training. Observation sessions of joint inspections of EUbased manufacturers (JI Ms), as part of Work Package 6 of the Joint Action Market Surveillance (JAMS) Programme were conducted. Inspections of local distributors and importers were also performed. The data collected through the questionnaire and observation sessions was applied for the development of a validated capacity-building framework, serving as a tool for EU NCAs to provide guidance on the required competencies of medical device regulatory inspectors. Results: Twelve European NCAs answered the questionnaire. Availability of inspectors (n=7) and integration of t he IT system - European Database on Medical Devices (EUDAMED) (n= 7), were the highest rated challenges faced by NCAs. Main areas in which inspectors require additional knowledge through training, include software as a medical device (n=7), followed by specialist processes (n=6), technical file review (n=4) and experience in design, manufacture and quality of medical devices (n=S). During the JI Ms (N=2) and local inspections (N=3), 'major' non-compliances in the quality management system, such as inadequate documentation control was identified in all of the inspections. Data obtained during phase 11, contributed to the development of a framework, incorporating EU NCA's and economic operators' perspectives through questionnaire results and noncompliances observed during inspections respectively. The framework includes sections: (i) key competencies for medical device regulatory inspectors, (ii) training and development, and (iii) competency evaluation and assessment. Conclusion: The developed framework can be applied as a guidance document, which supports workforce capacity building. Identification of expertise and essential inspector skil Is across EU NCAs strengthens inspectors' capacity to perform effective inspections and improve regulatory compliance.