The Commission published on August 19 the Implementing Regulation (EU) 2020/1207 laying down rules for the application of the MD Regulation as regards common specifications for the reprocessing of single-use devices.
This implementing Regulation lays down rules where national law has permitted reprocessing and a Member State has decided not to apply all the rules relating to manufacturers laid down in the MD Regulation.
It applies to single-use devices reprocessed and used in a healthcare establishment but also to those reprocessed by external reprocessor.
For more information, see the document.