Message 001
Communication from the Commission - TRIS/(2026) 2313
Directive (EU) 2015/1535
Notification: 2026/0440/PT
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20262313.EN
1. MSG 001 IND 2026 0440 PT EN 18-08-2026 PT NOTIF
2. Portugal
3A. Ministério da Economia e da Coesão Territorial
Instituto Português da Qualidade, I.P.
Rua António Gião, n.º 2
2829-513 Caparica
Telefone: + 351 21 294 81 00
Correio eletrónico: not1535@ipq.pt
site: www.ipq.pt
3B. Gabinete da Secretária de Estado da Saúde
Ministério da Saúde
Avenida João Crisóstomo, n.º 9
1049-062 Lisboa
Responsável pela elaboração do projeto – sandra.parreira@ms.gov.pt
4. 2026/0440/PT - S10S - Medical devices
5. New framework for in vitro diagnostic medical devices: a decree-law implementing Regulation (EU) 2017/746 in Portugal and laying down rules governing the manufacture, use, distribution, vigilance and supervision of these devices.
6. This legislation implements Regulation (EU) 2017/746 on in vitro diagnostic medical devices in Portugal, laying down rules governing their manufacture, use, distribution and supervision, as well as the applicable penalties, under the oversight of INFARMED, I.P.
7.
8. This Decree-Law implements Regulation (EU) 2017/746 on in vitro diagnostic medical devices in Portugal, establishing the legal framework applicable to the sector.
It defines the powers of INFARMED, I.P. as the competent national authority, regulates the manufacture, distribution and use of these devices, and establishes mechanisms for vigilance and market surveillance.
It also lays down traceability requirements, rules for healthcare institutions and a system of penalties designed to ensure compliance with legal obligations.
It is also based on the need to harmonise national law with existing European legislation.
9. The initiative aims to ensure the implementation of Regulation (EU) 2017/746 in the national legal order by creating a harmonised regulatory framework for in vitro diagnostic medical devices.
It aims to strengthen the protection of public health, guarantee high standards of quality, safety and performance for these devices, and ensure the proper functioning of the European Union’s internal market.
9a. The notified draft measure pursues objectives relating to the protection of public health and the health and safety of patients and users, ensuring the transposition into national law of Regulation (EU) 2017/746, which establishes the regulatory framework applicable to in vitro diagnostic medical devices.
The risk that the measure is intended to address is related to the need to ensure a high level of safety and health protection, while supporting innovation, in accordance with Regulation (EU) 2017/746, which, in turn, seeks to establish a robust, transparent, predictable and sustainable regulatory framework (there is no requirement to provide additional evidence, as the measure does not result from the independent identification of a risk requiring substantiation, but from the need to ensure the implementation of the Regulation).
The public interest is pursued in a consistent and systematic manner through an integrated regulatory framework, applicable throughout the life cycle of devices, as identified by its division into the following Chapters:
i. Chapter I sets out the general provisions, defines the scope of application and identifies INFARMED, I. P., as the competent national authority;
ii. Chapter II sets out the specific rules applicable to the sector and covers, inter alia, economic operators, healthcare institutions, the use and traceability of devices, notified bodies and vigilance mechanisms;
iii. Chapter III sets out obligations common to the various stakeholders;
iv. Chapter IV provides for inspection and enforcement activities and measures to protect public health, covering activities carried out throughout the devices’ life cycle;
v. Chapter V sets out the rules on administrative offences and penalties designed to ensure compliance with the obligations laid down; and
vi. Chapter VI contains the final and transitional provisions necessary for the regulation and effective application of the framework.
9b. The notified draft measure is not intended to create autonomous restrictions on trade or the cross-border provision of services, but to ensure, within the national legal system, the full implementation of the harmonised framework established by Regulation (EU) 2017/746, whilst respecting the principles of necessity and proportionality;
In this context, Portugal has adapted and strengthened the national legal framework governing in vitro diagnostic medical devices, ensuring that it is aligned with the new European framework and that the necessary instruments are in place to ensure its implementation and effectiveness.
9c. The burdens imposed on operators are justified by the nature and significance of the risks associated with in vitro diagnostic medical devices and are proportionate to the objectives pursued, without imposing excessive obligations on the functioning of the internal market;
The notified draft measure is related to another measure and does not result from an autonomous regulatory choice intended to impose restrictions on the functioning of the internal market.
10. References for the basic texts: No basic texts available
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
