# 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 4: Staff, premises and equipment

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

1. Reprocessors shall ensure that the personnel involved in the reprocessing:
(a) is sufficient in number to ensure the quality of the reprocessing;
(b) has the relevant specific knowledge and sufficient professional training in view of the reprocessing steps applied;
(c) has clearly defined tasks and responsibilities laid down in writing.
2. Reprocessors shall designate one or more persons responsible for the reprocessing.
3. The person responsible for reprocessing shall comply with the following criteria:
(a) has sufficient experience and qualification in the domain of reprocessing;
(b) has received training on reporting incidents and on undertaking critical analysis in accordance with Article 23(8).
The person responsible for reprocessing shall be permanently and continuously available to the reprocessor during working hours of the reprocessor. The person responsible for reprocessing shall also be responsible for the elaboration and management of the technical documentation referred to in Article 9 and of the QMS referred to in Article 21.
4. The premises where the reprocessing is taking place and the equipment to be used shall be adapted to the type of single-use devices to be reprocessed, the steps of the reprocessing cycle and the number of reprocessing steps.
5. The surfaces of the premises, ambient air (temperature, humidity, viable and non-viable airborne particles), water and other gases and fluids shall be controlled and periodically monitored to verify that their microbiological and physical quality is adequate for reprocessing.
6. The equipment shall be subject periodically to generally acknowledged state-of-the-art maintenance, performance checks, and calibrations, according to the manufacturer’s instructions. The equipment shall be validated and, where applicable, periodically revalidated, in order to establish that it is suitable for the intended purpose.
7. The reprocessor shall describe in the technical documentation referred to in Article 9(1) the types of single-use devices for which the reprocessor has decided that it has the ability to conduct reprocessing and the justification for that decision. The reprocessor shall make publicly available the list of devices that it is able to reprocess.
8. If the reprocessor decides that it has no longer the ability to reprocess certain types of single-use devices it shall describe the reasons of that decision in the technical documentation referred to in Article 9(1). The list referred to in paragraph 7 of this Article shall be updated accordingly.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.