Article 1–Article 2 · 2 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)
‘reprocessor’ means the health institution and the external reprocessor reprocessing single-use devices;
(2)
‘external reprocessor’ means the entity reprocessing single-use devices at the request of a health institution;
(3)
‘reprocessing cycle’ means a cycle that includes all reprocessing steps applied to a single-use device to ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
