Article 3 Contracting external reprocessors
United Kingdom
If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.
The contract shall include the following elements:
the attribution of tasks, obligations, and responsibilities of the two parties;
the arrangements for transition from one external reprocessor to another and responsibilities of the external reprocessor that is a party to the contract;
the requirements related to the qualification and expertise of the personnel participating in the reprocessing activities;
the requirements for the reprocessing, collection of information related to the reprocessed devices and information exchange between the health institution and the external reprocessor;
the requirement to ensure compatibility of the quality management systems (QMS) of the parties, as referred to in Article 21;
the procedure for monitoring of the quality of the reprocessing performed by the external reprocessor via on-site audit(s).