Possibility of reprocessing and further reuse of single-use medical devices approved in Denmark

On January 1, 2025, an amended Executive Order on Medical Devices entered into force, which makes it possible to send single-use medical devices for reprocessing and further reuse. At the same time, it ensures that the reprocessed devices are safe and effective to use on an equal footing with the original CE-marked devices:

• The climate and health agenda is generally receiving increasing attention – including how medical devices can help reduce the impact of climate change. In addition, there is concern about the supply of medical devices in the European Union;
• The amendment is based on Article 17(2) of the Medical Devices Regulation (MDR);
• As a result of the amendment, the so-called reprocessor takes over all the manufacturer's obligations and responsibilities for the device. The reprocessor also CE-marks the device again and is responsible for its safety and performance;
• Rules for in-house reprocessing have not yet been established.

Previously, in August 2023, the Ministry of Interior and Health set up a working group to help establish national rules for the reprocessing and further reuse of single-use devices. The Danish Medicines Agency acted as coordinator for the working group, which made its recommendations in May 2024. A monitoring group consisting of relevant external stakeholders has also been established in parallel with the working group. The working group recommended allowing Article 17(2) of the Medical Devices Regulation (MDR) via an amendment of the Executive Order on Medical Devices. The Danish Medicines Agency (Lægemiddelstyrelsen) can be contacted in case of any questions via email.

See the full details in Danish here and here.

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