European Commission sets common specifications for reprocessing single-use devices

Regulatory NewsRegulatory News | 21 August 2020 |  By 

The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).
Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.
The regulation includes several changes from the draft version released for comment in July 2019. (RELATED: EC offers specifications for reprocessing single-use devices under MDR, Regulatory Focus 25 July 2019).
Some of the sticking points present in Article 5, which sets standards for the preliminary assessment of the suitability of single-use devices for reprocessing, remain unchanged from the draft version. Reprocessors are now instructed to take into account the device’s previous use, and the article has been updated to reflect the delayed launch of Eudamed.
Article 5 also sorts out one of the issues raised by industry pertaining to the requirement for health institutions to review technical documentation from manufacturers as part of their assessment of whether a single-use device can be reprocessed. (RELATED: Industry criticizes EC’s specifications for reprocessing single-use devices under EU MDR, Regulatory Focus 21 August 2019).
Industry groups had questioned the legal basis for providing such documentation and noted that such information is proprietary. The regulation now clarifies that health institutions should review publicly available information from the website of the manufacturer or its authorized representative, in addition to other information in the public domain.
Reprocessors are now tasked with establishing a monitoring process to verify the marketing status of the single-use devices they reprocess. Specifically, reprocessors are instructed to verify “that the single-use device is not withdrawn from the market; that the certificate of conformity has not been suspended, withdrawn or is not subject to restrictions; [and] the use of the single-use device is not subject to restrictions for safety reasons.”
Article 7, which sets standards for determining the reprocessing cycle, has also been expanded to provide more detail to the validation, monitoring and the release of reprocessed single-use devices.
The regulation also clarifies how reprocessing cycles are counted, explaining that, “Each reprocessing cycle of a single-use device shall be counted to determine the maximum number of reprocessing cycles even if a single-use device was not reused on a patient following the reprocessing.”
Article 9 of the regulation, which covers technical documentation, now specifically calls for documentation to be retained according to the unique device identification-device identifier (UDI-DI) for each single-use device they reprocess. This includes the results of the suitability assessment, monitoring processes, tracking the number of uses of a single-use device, the system for reporting serious incidents and the system for identifying and disposing of single-use devices.
Much of the following chapters of the regulation are unchanged from the draft version, with minor changes to the procedures involved at various stages of the reprocessing cycle. The regulation also adds a requirement for health institutions to send a copy of serious incident reports to the original manufacturer and, where applicable, the external reprocessor. Additionally, the regulation no longer calls for the tracking system to record which patients reprocessed single-use devices have been used on.


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