Capacity building in the medical device regulatory inspectorate

Abstract

Introduction: Harmonised inspection strategies of medical device economic operators are considered as one of the arms of market surveillance activities within the 2017 European Medical Devices Regulations (MDR 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. Inspectors’ capacity can be enhanced through training, resource usage, technical help, assessment, feedback and collaboration.

Aims: 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 regulatory surveillance of medical devices.