Article 25 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.