Regulated Reprocessed / Remanufactured Devices Expand to EU

We have some important news coming out of the EU! Two months from now, on May 26 2020, the EU MDR will officially go into effect, thus establishing regulations for the medical device remanufacturing (also known as reprocessing) industry.

(Note: We understand the European Commission just announced it will consider asking Parliament in April delaying implementation of the EU MDR one year given health system stresses from COVID-19. AMDR and its members support whatever decision the Commission makes. Our information is intended to provide resources to decision makers so they base decisions on facts regardless of the deadline.)

Central to the regulations is the requirement that all EU hospitals discontinue the practice of in-house device reuse by the May deadline. Hospitals will then have the opportunity to send their used medical devices to an independent, regulated, professional remanufacturing facility. Time and again, when regulatory officials investigate the safety and capabilities of professional remanufacturing, they always choose it over in-house reprocessing.

Health officials are urging EU hospitals to take this step for several reasons, including patient and staff safety, real cost savings, and sustainable landfill diversion. Furthermore, opting in to regulated remanufacturing can free up critical financial resources at a time when hospitals are asked to dramatically increase their capacity. Follow the link below for the official press briefing.