Green pharmaceutical practices in industry : a review

Abstract

Introduction: Harmonised inspection strategies of medical device economic operators are considered one of the key components of market surveillance activities within the 2017 Medical Device Regulation (EU MDR 2017/745), enhancing the use of safe medical devices on the European market. Cooperation between regulatory bodies and the business sector is essential to ensure clarity and effectiveness in regulatory interpretation. Communication is strengthened through inspections of economic operators. Inspectors’ capacity can be enhanced through training, resource utilisation, technical support, 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 of this study 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 existing frameworks, including the number and type of inspections carried out, available expertise, and training plans of inspectors. The questionnaire included multiple-choice, closed, and open-ended questions. Respondents were requested to rate, using a 5-point Likert scale, the challenges faced by their respective NCA and the areas in which inspectors require further training. Observation sessions of joint inspections of EU-based manufacturers (JIMs), 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 were used to develop 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 responded to the questionnaire. The availability of inspectors (n = 7) and integration of the IT system—European Database on Medical Devices (EUDAMED) (n = 7)—were the highest-rated challenges faced by NCAs. The main areas in which inspectors require additional training include software as a medical device (n = 7), specialist processes (n = 6), experience in design, manufacture, and quality of medical devices (n = 5), and technical file review (n = 4). During joint inspections (JIMs, N = 2) and local inspections (N = 3), major non-compliances in quality management systems—such as inadequate documentation control—were identified in all inspections. Data obtained contributed to the development of a framework incorporating both EU NCA and economic operator perspectives, based on questionnaire findings and observed non-compliances. The framework includes the following 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 to support workforce capacity building. Identification of expertise and essential inspector skills across EU NCAs strengthens inspectors’ capacity to perform effective inspections and improve regulatory compliance.