In December 2020, the Swedish National Board of Health and Welfare (Socialstyrelsen) released a thorough and evidenced report: Prerequisites for Reprocessing and Reusing Disposable Medical Devices (original, and AMDR’s English version). The Association of Medical Device Reprocessors (AMDR) applauds the Swedish National Board of Health and Welfare’s work. Our statement on the report and its conclusions is available here.
Background
Article 17 of the European Union’s Medical Device Regulation (MDR) of 2017 puts in place stringent new EU-wide requirements for the reuse of “single-use” devices (SUDs). EU Member States have discretion on which path or paths to take, as outlined in the provisions of article 17, and the EU MDR is to be fully implemented by May of this year (2021). In short, any reuse of SUDs must both adhere to the safety and efficacy requirements of the MDR and be allowed by national law. The safety and regulatory requirements ensure reprocessors adhere to the same standards as applied to original equipment manufacturers (OEMs) and obtain a CE mark – often dubbed in Europe, “SUD remanufacturing” (the 17.2 provisions). . .
Link to AMDRs full response HERE.