List of single-use medical devices for which reprocessing is prohibited | Ministerial Order No. 206/2026/1

Ministerial Order No. 206/2026/1 was published today in the Official Gazette, approving the list of single-use medical devices for which reprocessing is prohibited within the national territory. 

The decree clarifies, for the purposes of clinical practice and regulatory compliance, which devices must not be reprocessed after use, for reasons of patient safety and the prevention of technical and clinical risks.

The Ministerial Order falls under the framework of Decree-Law No. 29/2024 and Regulation (EU) 2017/745, and is particularly relevant for hospitals, healthcare centres, other healthcare providers and sub-contracted entities working with single-use devices.

Devices covered by the prohibition include, for example, devices that emit radiation, devices used in the administration of cytostatic drugs or radiopharmaceuticals, devices incorporating medicinal substances, devices intended for invasive procedures on the central nervous system, eyes or pituitary gland, implantable devices, as well as devices with non-replaceable batteries, with essential internal data storage, or with blades, drills or other wear components. The list also includes custom-made devices and certain devices used in patients with neurological conditions of unknown origin.

The order will become effective on the day following its publication, 6 May 2026, and allows for the list to be revised whenever technical, scientific or clinical developments so warrant. 

For further information, read the full text of Ministerial Order No. 206/2026/1 here.