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Health institutions reprocessing single-use medical devices

Health institutions reprocessing single-use medical devices

As a health institution reprocessing single-use devices you 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.

As a reprocessor you 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)

Key Resources

  • Factsheet for health intitutions reprocessing single-use medical devices under preparation.
Related Resources

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Release Date : 1 January 2018 | Country : United Kingdom | Language : English

This briefing, aimed at anyone in NHS hospitals and organisations involved in the manufacturing or modification and use of medical devices and in vitro diagnostic medical devices, covers changes in the rules governing these activities.

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