Medical Devices - New regulations

Health institutions reprocessing single-use devices

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A health institution reprocessing single-use devices will have to comply with Article 17 of the MDR. The Regulation adds strict conditions for reprocessing of single-use medical devices, and places full product liability on the reprocessor.

In addition, reprocessing may only take place when authorised under national law and in accordance with the provisions of the MDR. Some EU countries may have stricter provisions, or even ban reprocessing.

EU countries allowing the reprocessing of single-use devices may decide not to apply all the rules relating to manufacturers’ obligations laid down in the Regulation (EU) 2017/745, if the single-use devices are reprocessed and used within a health institution. In such case, EU countries shall ensure that the safety and performance of the reprocessed device is equivalent to that of the original device and the reprocessing is performed in accordance with common specifications for the reprocessing of single-use devices.

The reprocessor must assume all responsibilities of the original manufacturer who will no longer be mentioned on the label (but will continue to appear on the Instructions for Use).

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