Reprocess Of Single Use Devices: EU MDR Requirements

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The requirements related to the reprocessing of single use devices are reported within Article 17 of EU MDR 2017/745. Several articles have been already published related to EU MDR and related to the requirements for single use devices, including the ISO 17664 focused on the processing instructions to be supplied by the manufacturer.

In this article, we will focus on the requirements related to the reprocessing of single use devices according to EU MDR 2017/745.

Before starting the discussion on the specific requirements, let’s remind the definition of reprocessing, as per article 2 of EU MDR: a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.

Overview of Article 17 of EU MDR 2017/745

First of all, it is important to remind that reprocessing of single use devices is possible only if it is allowed by the national law of the specific country; obviously for devices with CE marking, the requirements related to Article 17 shall be fully respected.

The concept of the manufacturer of the reprocessed device is also very important. Any natural of legal person that reprocesses a single use device shall be considered the manufacturer of the reprocessed devices and shall be obliged to assume all the obligations set within EU MDR 2017/745.

In case there is no difference in the safety between the original device and the reprocessed one and in case the reprocessing activity is performed according to the related Common Specifications, the obligations set within EU MDR may not be applied.

We have already been discussing about the Common Specifications related to reprocessing of single use device in this specific article. In general, this Common Specification shall define the obligations for the following topics.

The requirement set by this Common Specifications shall be applicable in case the reprocessing activity is performed by an external Reprocessor, in case this si requested by a health institution.

The name and address of the legal or natural person referred that performs the reprocessing activity and shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.

Labelling Information for Reprocessed Single Use Devices

There are some specific requirements related to the labelling of the reprocessed single use devices; these requirements are established within Annex I of EU MDR 2017/745. If the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles shall all be included in the Information for Use.

Moreover, reprocessed single-use devices shall bear the word “reprocessed” on their label, as well as the status of the single-use device: “disinfected” or “sterilised” followed by the disinfection or sterilization method, and the shelf life. Furthermore, the name and address of the health institution, and the external reprocessor (if applicable), shall be clearly indicated on the label and in the instructions for use of the single-use device.

Traceability Requirements for Single Use Reprocessed Devices

Traceability shall be kept throughout the reprocessing cycle and the lifetime of the reprocessed single-use device. The traceability system shall ensure the following:

the number of reprocessing cycles that the single-use device has undergone is recorded;
the health institution verifies that the single-use device reprocessed by the external reprocess or and returned to the health institution is the same single-use device that was used in the health institution concerned and sent to the external reprocessor for reprocessing.

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