Digitalisation of regulatory activities for medical devices

Abstract

As the designated national competent authority (NCA), the Malta Medicines Authority (MMA) inaugurated the Medical Devices and Pharmaceutical Collaboration Directorate (MDPCD) in 2020, to monitor all medical devices placed on the local market and ensure their safe use. The recent transition to a new regulatory framework for medical devices in the European Union (EU) pose the need for digitalisation to reinforce and improve the regulation of medical devices, on a local scenario. The study aimed to evaluate the current systems of regulatory activities for medical devices, identify opportunities for digitalisation and develop a guideline for the implementation of Unique Device Identification (UDI). The present systems were analysed through observation sessions, interviews and access to relevant documentation at MMA and the Central Procurement and Supplies Unit. Findings were analysed thematically and formed the basis for the establishment of interviews and focus group discussions with MMA and its stakeholders --- national health system (NHS) working group and industry representatives. The results were transcribed to facilitate strengths, weaknesses, opportunities, and threats (SWOT) analyses. The stakeholders shared a main strength – conduct of online sessions and availability of local guidelines for medical device-related registrations. Both groups had varied weaknesses and opportunities. The NHS group focused on the improvement of the incident reporting process, while the industry was concentrating on the efficient enforcement of the medical device notifications. A common threat identified was the perspective, both of economic operators and clinical users, on the change in regulatory framework for medical devices in the EU. The results revealed the systems in place which should be maintained and allowed identification of gaps and act accordingly on areas of improvement. Recommendations for application of digitalisation to enhance the efficiency of handling medical device-related incident reports were put forward, and short guideline for UDI implementation was presented. This study also uncovered the overall performance of MMA as the NCA and the present situation of local medical device regulation.