# 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 3: Contracting external reprocessors

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

1. If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.
2. The contract shall include the following elements:
(a) the attribution of tasks, obligations, and responsibilities of the two parties;
(b) the arrangements for transition from one external reprocessor to another and responsibilities of the external reprocessor that is a party to the contract;
(c) the requirements related to the qualification and expertise of the personnel participating in the reprocessing activities;
(d) the requirements for the reprocessing, collection of information related to the reprocessed devices and information exchange between the health institution and the external reprocessor;
(e) the requirement to ensure compatibility of the quality management systems (QMS) of the parties, as referred to in Article 21;
(f) the procedure for monitoring of the quality of the reprocessing performed by the external reprocessor via on-site audit(s).

---
Source: https://www.legislation.gov.uk/eur/2020/1207/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.