Article 1 Subject matter

This Regulation lays down rules for the application of Article 17(3) of Regulation (EU) 2017/745, where national law has permitted reprocessing of single-use devices and a Member State has decided not to apply all of the rules relating to manufacturers’ obligations laid down in that Regulation as regards single-use devices that are reprocessed and used within a health institution.

This Regulation also lays down rules where a Member State has chosen to apply Article 17(3) of Regulation (EU) 2017/745 also as regards single-use devices that are reprocessed by an external reprocessor.