MDR: Common specifications for reprocessing of single-use devices -- MEDICA - World Forum for Medicine

17.11.2020

Obelis S.A. Obelis European Authorized Representative Center

MDR: Common specifications for reprocessing of single-use devices

The MDR (Regulation (EU) 2017/745) allows reprocessing of single-use devices only where it is permitted by national law. In fact, when reprocessed and used within a health institution, the MDR allows Member States not to apply all the rules relating to manufacturers’ obligations laid down in that Regulation (Article 17(3)). However, one of the conditions for such reprocessing is that it is performed in accordance with common specifications (‘CS’).

Exhibitor Data Sheet