Reprocessing and further use of single-use medical devices to be permitted?
Article 17(1) of Regulation 2017/745(EC) on medical devices ("MDR") stipulates that reprocessing and further use of single-use devices are only allowed where permitted by national law. It further follows from Article 17(2) that any natural or legal person reprocessing a single-use device to make it suitable for further use within the EU shall assume the manufacturer's obligations as laid down in the MDR.
In August 2023, the Danish Ministry of Health established a working group on the "reprocessing and further use of single-use medical devices" to assist in stipulating national rules for reprocessing and reusing single-use equipment.
In May 2024, the working group recommended an amendment to the executive order on medical devices (Executive Order No. 837 of 20 June 2023). The working group proposed that reprocessing and further use of single-use medical devices shall be permitted by national law in accordance with Article 17(2) of the MDR.
The purpose of the amendment is to boost the existing market for single-use medical devices and encourage manufacturers of original equipment to produce recyclable and reprocessed equipment to benefit supply security and the environment.
If approved, the executive order will enter into force on 1 January 2025.
The Danish Ministry of Health has set the deadline for submitting consultation responses to 26 November 2024.