# 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 6: Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device

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

1. Reprocessors shall not change the original intended purpose of the single-use device as indicated in its instructions for use.
2. Reprocessors shall establish a monitoring process to verify the following:
(a) that the single-use device is not withdrawn from the market;
(b) that the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions;
(c) the use of the single-use device is not subject to restrictions for safety reasons based on the information referred to in Article 5(3), (b) and (c);
The reprocessors shall also identify any change made by the manufacturer to components, materials, intended purpose or specifications of the single-use device that may have an impact on the reprocessing. Reprocessors shall assess the significance of these changes for the appropriateness of reprocessing. If a change has a detrimental effect on the reprocessed single-use device, reprocessing shall be discontinued or the reprocessing process shall be modified to adapt to the change made to the single-use device.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.