Capacity building in medical device regulatory inspectorate

Abstract

Harmonised inspection strategies of medical device economic operators are considered as one of the arms of market surveillance activities within the 2017 medical device regulations (EU MDR 2017/745), that enhance the use of safe medical devices on the European market. The aim of the study was to establish a capacity-building framework for medical device inspectors within European National Competent Authorities (EU NCAs), presented as a structured guidance document. The study methodology comprised of three phases. Phase I had a two-pronged approach. A literature review of peer-reviewed articles, along with an analysis of stakeholder feedback received as part of the EU Commission’s initiative, were carried out. Phase II consisted of the dissemination of a validated questionnaire to medical device regulatory inspectors to evaluate practices, training and gaps encountered. Observation sessions of joint inspections of EU-based manufacturers (JIMs), as part of the Joint Action Market Surveillance (JAMS) Programme, and local inspections of distributors and an importer, were carried out to identify encountered non-compliances in a real-world scenario. The outcomes of the first two phases of the study were applied in the development of a validated capacity-building framework. Out of the identified 46 articles reviewed, 11 articles stated that some medical devices are at risk of market withdrawal, as a consequence for the need of exceptional market approvals. A potential disruption to the medical device market is brought on by an increase in cost (n= 20) faced by all parts of the supply network, as identified from the analysis of responses of the targeted evaluation (N=100). In Phase II, 11 EU NCAs replied to the validated questionnaire. The lack of technical expertise (n=7) and IT system integration (n=7), were the highest rated challenges identified by EU NCAs. During the JIMs (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. The guidance document developed consisted of 6 sections, featuring: (i) inspectorate strategy overview, (ii) competency categories, and (iii) training. The developed framework is intended to serve as a training and competency-based reference tool in the area of the medical device regulatory sciences.