[Impact of the new European regulation 2017/745 on medical devices on hospital pharmacies activity: Example on pharmaceutical supply function within a French university hospital center]

Abstract

Objective: The new European regulation (MDR) on medical devices (MD) is expected to have major impacts on the industrial sector, but also consequences on healthcare professionals. Our objective was to evaluate the impact of the MDR on the supply of MDs in hospital pharmacies at the level of a French university hospital.

Material and methods: We conducted a prospective follow-up of marketing cessations and supply disruptions directly related to the MDR between November 2019 and September 2020. The data were analyzed accounting for the nature of the suppliers (status/size), the nature of the MDs (route/class), and the proposed alternatives. The economic impact on hospital pharmacies was also estimated.

Results: Over this period, 96 MD product designations were declared out of stock or in cessation (total of 402 references), of which half corresponded to class IIa MDs, mainly used for surgical procedures. Of the 14 companies concerned (36% French), the majority were manufacturers, of small/medium-size or intermediate size. Substitutions were proposed for only 15 products (15.6%). The cost of pharmaceutical management of these disruptions/marketing cessations was estimated at 3052€.

Conclusion: Even before the official date of its application, the impacts of the MDR on the supply function of hospital pharmacies are already visible. In the short, medium and long term, prospective monitoring of the impacts, positive or negative, would seem to be justified at the level of manufacturers, healthcare professionals and end users of MDs.

Keywords: 2017/745 Regulation; Approvisionnement; Dispositifs médicaux; EC marking; Hospital pharmacy; Marquage CE; Medical devices; Pharmacie hospitalière; Règlement 2017/745; Supply.