Single-use reprocessing: the Article 17 route few hospitals use

Article 17 of the MDR allows a health institution to reprocess single-use devices and use them within the same institution, provided the conditions on cleaning, sterilisation, and traceability are met. The exemption is narrower than it is often assumed to be: the reprocessed device cannot be placed on the market or used by another institution, and the hospital must be able to demonstrate that the process does not compromise safety.

Where a hospital does not want to carry the full quality management burden, an external reprocessor can act instead. In that case the reprocessor is treated as the manufacturer of the reprocessed device, must hold a CE certificate, and takes on the corresponding liability. That shift of responsibility, rather than the cost of the process itself, is the main reason the external route dominates in practice.

The economics remain contested. Instrument sets that are costly and robust, such as certain orthopaedic and electrophysiology components, can justify reprocessing on cost grounds. Devices with complex internal channels or materials that degrade through repeated cycles often do not, once validation, quality control testing, and administrative overhead are counted against the price of a new device, which in volume production is often lower than hospitals expect.

Hospitals considering either route should start with a device-level risk assessment and a review of the manufacturer's own instructions for use, which may state that reprocessing is not supported. Regulatory expectations here are strict, and the documentation burden falls on the institution rather than on the original supplier, including records that must be retained for the lifetime of the device.