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SubscribeOn 5 May, Order No. 206/2026/1 was published, which defines the list of single-use medical devices whose reprocessing is prohibited, in implementation of the provisions of the national regime applicable to medical devices.
This Order follows Decree-Law No. 118/2025, of 13 November, which amended the medical devices regime and introduced the provision that single-use devices not susceptible to reprocessing would be defined by ministerial order — a topic we had the opportunity to address in the publication “New Changes for Medical Devices".
List of covered medical devices
The new list maintains the prohibition on reprocessing the following single-use devices:
- Radiation-emitting devices;
- Devices used to administer cytostatic drugs or radiopharmaceuticals;
- Devices incorporating medicinal substances;
- Devices for use in invasive procedures of the central nervous system, eyes, or pituitary gland;
- Devices that pose a risk of transmission of spongiform encephalopathies;
- Implantable devices;
- Devices with batteries that cannot be replaced or that present a risk of malfunction after reprocessing;
- Devices with internal data storage necessary for the use of the device that cannot be replaced or that present a risk of malfunction after reprocessing;
- Devices with cutting or scraping blades, drills, or other wear components that are no longer suitable after first use and that cannot be replaced or adjusted before the next medical procedure;
- Devices whose original device has already been reprocessed by another entity or by another process;
- Custom-made devices;
- Devices manufactured and used only in healthcare institutions, provided the requirements set out in the European Medical Devices Regulation are met (Article 5(5));
- Products without a medical purpose but covered by the European Medical Devices Regulation, such as contact lenses or other articles intended to be introduced into the eye or placed on it, as identified in Annex XVI of the Regulation;
- Single-use devices used on patients with a neurological condition of unknown origin, which includes at least two of the following symptoms: progressive dementia, myoclonus, or ataxia.
Thus, in substantive terms, the new Order largely maintains the previously applicable list. The most relevant change appears to be the exclusion of devices intended for invasive procedures of the central circulatory system from the list of devices whose reprocessing is prohibited.
Practical Impact on the Industry
From a practical standpoint, this update does not introduce significant changes for the majority of economic operators and healthcare institutions. Nevertheless, the new model — which delegates the definition of these devices to a ministerial order — allows for a more agile update of the list in the future.
In this context, it will be important for the industry and healthcare institutions to closely monitor any future changes, given the direct impact these may have on operational management and on the reprocessing processes of medical devices.
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