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.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 2 of Commission Implementing Regulation (EU) 2020/1207 (LawPlayer, data as of 2026-07-04)
