Decree-Law No. 29/2024 and Medical Device Compliance in Portugal: Learn About the Main Changes
New Decree-Law No. 29/2024 on Medical Devices
On April 5, Decree-Law No. 29/2024 was published, ensuring the national implementation of Regulation (EU) 2017/745 concerning medical devices (commonly known as MDR – Medical Device Regulation). This new legislation introduces several changes to national law, adapting the legal framework for medical devices and their accessories to the requirements of the Medical Device Regulation.
Main Changes
With the entry into force of the MDR, it became necessary to reformulate national legislation regarding medical devices, leading to the repeal of the previous Decree-Law No. 145/2009. This law established the rules related to the investigation, manufacture, commercialization, entry into service, surveillance, and advertising of medical devices and their accessories.
Decree-Law No. 29/2024 now regulates a set of essential aspects for economic operators and healthcare institutions that produce and use medical devices on their premises. It includes rules on the use and traceability of devices, as well as the appointment and supervision of the activities of notified bodies. It also specifies the conditions and requirements necessary for the reprocessing and use of single-use reprocessed devices in the national territory, ensuring their safety and performance.
Legal Framework and Oversight
This decree-law establishes a detailed framework that, in conjunction with the MDR, aims to ensure safety at all stages of the medical devices’ life cycle, from design to final use. In addition to regulating the activities of manufacturing, importing, distributing, and using medical devices, the law emphasizes the discipline applicable to devices manufactured and used in healthcare institutions. It also introduces specific standards for the traceability of these devices, ensuring effective monitoring throughout their life cycle.
Market supervision and oversight are reinforced through INFARMED, I.P. as the competent national authority, which has expanded powers to enforce compliance with the new standards.
EUDAMED
Decree-Law No. 29/2024 establishes a transitional regime, temporarily maintaining some rules of Decree-Law No. 145/2009 in force. Until the implementation and operationalization of the European database on medical devices (EUDAMED), economic operators must comply with the notification and registration obligations applicable in Portugal. This transitional regime includes specific obligations for manufacturers, authorized representatives, and distributors, ensuring the continuity of regulation until the full adoption of the new system.
INFARMED Informative Mornings
To facilitate the transition and clarify the stakeholders on the impact of Decree-Law No. 29/2024, INFARMED, I.P. organized an Informative Morning session on June 27, 2024. For more information, consult the presentations from the Informative Mornings at the following link.
Effective Date
Decree-Law No. 29/2024 came into effect on April 6, 2024, with an effective date of 90 days after its publication. Therefore, the application date is July 4, 2024. From this period, it is expected that all entities will have adapted to the new legal requirements, ensuring the continued safety and effectiveness of medical devices in the national market.
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