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Reprocessing refers to the method through which you can reuse medical devices safely and effectively. The European Union Medical Device Regulation (EU MDR) 2017/745 describes the word “reprocessing” as exclusively used for single-use devices, while it describes the reprocessing of reusable devices as “the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilization appropriate to the member state or the member states in which the device has been placed on the market. “
In the EU, the national law determines the placing of reprocessed devices in a particular region. In case the country allows the placing of reprocessed devices, the manufacturers need to follow Article 17 of the EU MDR.
Regulations for Reprocessed Devices
Companies that reprocess single-use devices are considered manufacturers of the reprocessed devices and not the manufacturers who originally developed the device. They are required to comply with the general obligations of manufacturers under Article 10 of the EU MDR. While the obligations may not apply to the health institution that uses reprocessed devices internally, they are still required to provide substantial evidence. The primary requirement is that the performance and safety of the devices should be equivalent to the original device and they should meet the requirements in the EU MDR Article 5(5) points (a), (b), (d), (e), (f), (g), and (h). The manufacturers should carry out the reprocessing of devices as per the common specifications.
In August 2020, the European Commission (EC), through its common specifications, published a set of harmonized standards for the reprocessing of single-use devices. It lays out detailed requirements with respect to the resources, Quality Management System (QMS), cycles of reprocessing, vigilance, traceability, etc. This document is intended for both health institutions and external reprocessors.
In case where health institutions hire external reprocessors (organizations), both parties need to sign a contractual agreement, which should be presented in a clear and legible written format.
Steps for Reprocessing a Device
The first step in reprocessing is the preliminary assessment, which refers to the assessment of the device prior to reprocessing. The foremost consideration guiding this step is if the single-use device is suitable for reprocessing. The person carrying out the reprocessing should be an expert at the job and must be able to determine the suitability. The verification of Conformité Européene (CE) marking, along with any restrictions or recalls, is also necessary at this stage.
The reprocessor is required to determine the reprocessing cycles and the maximum number up to which they can reprocess the device. They are also required to prepare the technical document that should be unique to each model. Moreover, the reprocessors need to establish, document, and implement the QMS for reprocessing activities. They must keep audit reports, incident reports, records on the traceability of devices, and other relevant records. The documents should be maintained for up to ten (10) years after the last reuse of the device.
The next step involves the identification of appropriate procedures for cleaning, sterilization, thermal disinfection, chemical disinfection, drying, and transporting. Subsequently, procedures for inspection, maintenance, and repair follow. The main purpose of these procedures is to validate the method and performance of the reprocessed device.
Post establishing and validating the methods, the reprocessed device is packaged and labeled. The packaging of the device, along with the Instructions for Use (IFU), does not have to bear the CE mark. In case of labeling, the name and contact information of the health institution or external re-processor (whichever/wherever applicable) is required to be affixed on the device. Moreover, the device should incorporate the reprocessing, the status of the device (sterilized, disinfected, etc.), the method of sterilization/disinfection, and the shelf life. It shall also bear the maximum number of reprocessing cycles and the status of the same.
Conclusion
Drafting these rules for implementation is crucial for placing the reprocessed device on the EU market, and one should be quite careful while implementing the regulations owing to their detailing and complexity. We understand that the process is a complex one; Freyr, with its robust model of Regulatory services, can support you with placing reprocessed devices in the EU market. For any queries, reach out to us. Stay informed! Stay compliant!
