# 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 19: Packaging

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

1. Procedures for packaging referred to in point (h) of Article 11 shall cover the following, if applicable:
(a) material specification;
(b) compliance with the specific sterilization or disinfection method;
(c) limits on packaging process parameters, including sealing temperature;
(d) criteria for acceptance or rejection.
2. The packaging and the instructions for use of the reprocessed single-use device shall not bear the CE mark.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/19 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

