Article 24–Article 26 · 3 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Tracking of reprocessing cycles
1. Reprocessors shall put in place a tracking system allowing the identification of the single-use device throughout the reprocessing cycle and the lifetime of the reprocessed single-use device.
This tracking system shall ensure the following:
(a)
record the number of reprocessing cycles that the single-use device has undergone;
(b)
ensure that the health institution verifies that the single-use device reprocessed by the external reprocessor and returned to the health institution is the same single-use device that was used in the health institution concerned and sent to the external reprocessor for reprocessing.
2. The tracking system shall ensure that reprocessed devices can be linked to the correct batch number for the purposes of field safety corrective action in accordance with Article 89 of Regulation (EU) 2017/745.
Records
Reprocessors shall store all records regarding all steps of the reprocessing cycle, for a period of at least 10 years after the last reprocessing of a single-use device. The health institution and the external reprocessor, shall make those records available to the notified body competent for the certification referred to in Article 17(5) of Regulation (EU) 2017/745 and, upon request, to authorities of the Member States.
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 26 May 2021.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
