# Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance), Article 8: Maximum number of reprocessing cycles

Extent: E+W+S+N.I.

1. Each reprocessing in accordance with Article 11 shall be counted as one reprocessing cycle. Each reprocessing cycle of a single-use device shall be counted to determine the maximum number of reprocessing cycles even if a single-use device was not reused on a patient following the reprocessing.
2. The health institution, together with the external reprocessor, when applicable, shall determine the maximum number of reprocessing cycles which can be applied to the reprocessed single-use device, during which the performance and safety of that single-use device remains equivalent to the original single-use device.
3. Once the maximum number of reprocessing cycles has been reached, the reprocessed single-use device shall be disposed of.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/8 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.