Commission Implementing Regulation (EU) 2020/1207Show full title

Article 9 U.K. Technical documentation

1. Reprocessors shall have a technical documentation on its reprocessing activities which shall include:

(a) the procedures for controlling and periodically monitoring premises and equipment referred to in Article 4(5) and (6);

(b) any decision concerning the ability or lack of ability to reprocess a type of single-use devices.

2. Reprocessors shall also have a technical documentation specific to each model of single-use device, manufactured by the same manufacturer, as identified by its device identifier in the Unique Device Identification system (‘UDI-DI’). The technical documentation shall include:

(a) the results of the determination of the reprocessing cycle and procedures referred to in Article 7;

(b) the actions to be undertaken in case one or more steps of the reprocessing cycle have not been performed.

3. The technical documentation specific to each model of single-use device manufactured by the same manufacturer, as identified by its UDI-DI that is kept by health institutions, shall also include:

(a) the results of the assessment of the suitability of the single-use device for reprocessing described in Article 5 and the data and information used for the assumption that the safety and performance of the reprocessed device will be equivalent to those of the original single-use device;

(b) the results of the monitoring process referred to in Article 6;

(c) the description of the system for tracking the single-use device from the first use until its last reuse;

(d) the description of the system for reporting serious incidents in accordance with Article 23;

(e) the description of the system to identify and to dispose of the single-use device if it fails to meet any aspect of functionality, performance or safety, prior or during reuse.

4. The technical documentation shall be kept for 10 years after the last reuse of a single-use device.