Prohibition on the Reprocessing of Single-Use Medical Devices

On May 5, 2026, Ordinance No. 206/2026/1 was published, which, pursuant to Decree-Law No. 29/2024, ensuring the implementation in the national legal order of Regulation (EU) of the European Parliament and of the Council of April 5, 2017, on medical devices (“Regulation 2017/745“), approves the list of single-use medical devices whose reprocessing is prohibited within the national territory, entering into force on the day following its publication.

Devices Covered by the Ban

The list attached to the Ordinance includes, in particular:

Devices that emit radiation or are used in the administration of cytostatic agents or radiopharmaceuticals;
Devices that incorporate medicinal substances;
Implantable devices or devices for invasive use in the central nervous system, eyes, or pituitary gland;
Devices posing a risk of transmitting spongiform encephalopathies;
Devices with non-replaceable batteries or posing a risk of malfunction after reprocessing;
Custom-made devices or those already reprocessed by another entity or process;
Devices used in patients with neurological conditions of unknown origin, presenting at least two of the following symptoms: progressive dementia, myoclonus, or ataxia.

The list may be revised based on advances in technical, scientific, and clinical knowledge.

Practical Impact

The Ordinance takes effect immediately for hospitals, hospital centers, healthcare facilities, and subcontractors duly registered with the Health Regulatory Authority, which must revise their internal medical device management processes accordingly.

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