Decree-Law 118/2025 has been published, introducing amendments to and corrections of inaccuracies in the medical devices regime
Don’t miss our content
SubscribeOn November 13, 2025, Decree-Law 118/2025 was published, introducing amendments to and corrections of inaccuracies in Decree-Law 29/2024 of April 5 (“Medical Devices Regime”). The Medical Devices Regime implements Regulation (EU) 2017/745 on medical devices (“European Medical Devices Regulation”).
For a broader understanding of the implications arising from this new regime, please refer to our article, “Implementation of the Medical Devices Regulation,” where we analyze the main practical impacts on the medical device industry in Portugal.
Although the primary purpose of Decree-Law 118/2025 is to correct identified inaccuracies in the Medical Devices Regime, the legislator also seized the opportunity to make certain adjustments regarding reprocessing procedures and the framework applicable to single-use devices. Below we summarize the main amendments.
Main amendments to the Medical Devices Regime
Written procedures for reprocessed medical devices:
The amendments clarify that the obligation to maintain written procedures for reprocessing applies exclusively to operators who lend medical devices.
The updated wording eliminates previous uncertainty about whether this obligation extended to health institutions. The amendments expressly establish that operators responsible for making medical devices available on a loan basis must ensure the existence and maintenance of these written records if they assume the agreed responsibility to reprocess the devices.
Prohibition on reprocessing single-use devices:
Decree-Law 118/2025 also changes the framework governing the prohibition of single-use device reprocessing.
The list of devices for which reprocessing is prohibited is no longer directly included in the Medical Devices Regime; instead, it will now be approved by an ordinance to be issued by the Ministry of Health.
Despite this procedural change, the prohibition on reprocessing single-use devices within Portugal remains fully in force.
Deadline for reassessment of notified bodies:
Decree-Law 118/2025 harmonizes the reassessment period for notified bodies established (or to be established) in Portugal. In line with the European Medical Devices Regulation, a reassessment periodicity is now uniformly set at every five years.
Entry into force
These amendments will take effect on January 12, 2026.
Industry impact and endnotes
The recently published amendments necessitate particular attention from manufacturers, distributors and healthcare institutions regarding the reprocessing of single-use devices. Specifically, stakeholders should closely monitor developments in the forthcoming ordinance issued by the Ministry of Health, as this will list the single-use devices for which reprocessing is prohibited. Given the ordinance’s dynamic nature, it could have direct implications for operational management.
Also, the national legal framework for implementing Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR Regulation) has yet to be approved. The publication of this framework will play a decisive role in clarifying the framework applicable to this subsector, ensuring legal certainty for operators.
Don’t miss our content
Subscribe