Article 22 Annual audit

Reprocessors shall undertake at least one annual independent external audit of the reprocessing activities. The audit report shall be made available to the notified body competent for the certification of the reprocessor pursuant to Article 17(5) of Regulation (EU) 2017/745 and, upon request, to the competent authority of the Member State where the reprocessor is established.

The reprocessing processes and the QMS shall be revised, as needed, on the basis of the results of the independent external audit.

The audit report and the documentation related to the eventual follow up actions shall be kept for a period of five years.