New law on clinical research in medical devices and IVDs

Law No. 71/2025, published on December 22, 2025, finally implements in the Portuguese legal system the provisions of Regulations (EU) 2017/745 ("MDR") and 2017/746 ("IVDR") regarding clinical research with medical devices and performance studies of in vitro diagnostic medical devices (IVDs), clarifying procedures and consolidating national competences, divided between Infarmed and national Ethics Committees.

Scope and framework

The law establishes the regime applicable to the approval processes and the conduct of clinical investigations of medical devices and performance studies of IVDs, thus replacing the legislative framework in force until today.

In practice, this means that:

• Interventional clinical studies of medical devices and performance studies of IVDs are now regulated exclusively by European regulations – MDR and IVDR – and by this new Law No. 71/2025.
• Interventional clinical studies of medical devices, also called observational studies, remain regulated by Law No. 21/2014, of 16 April, in its current wording ("Clinical Research Law").

What changes?

The new law that now regulates clinical studies with medical devices and devices for in vitro diagnosis thus creates an independent regime for the regulation of these studies, although very similar to the practice that, since the application of the MDR and IVDR, already characterizes the approval and implementation of these studies in Portugal. Thus, we highlight some of the most relevant legislative novelties:

• Clear distinction between authorisation and notification: the new Law no. 71/2025 implements in the legal system the authorization and notification procedures already resulting from the MDR and the IVDR, distinguishing between the approval and notification processes, and establishes the electronic processing applicable to them, as well as to substantial changes (through the EUDAMED platform, to be used when the clinical research module becomes mandatory).
• Rules for the protection of the most demanding participants: express provision for written consent from the age of 16 for minors, respect for the minor's will and clarification of the effects of the age change during the study.

It is relevant to note that this change is also reflected in the draft law that implements the Clinical Trials Regulation in the Portuguese legal system that is currently in the legislative process, thus aimings to the regulation between interventional studies of medical devices and studies with intervention of medicinal products.

• Traceability: there are now specific rules that regulate the traceability, storage, return and destruction of the experimental devices, to be observed by the study sites, and the procedures must be included in the authorization or notification documentation of the study.
• Language requirements:  linguistic requirements are now provided for the documentation addressed to participants, namely labelling and instructions for use of experimental devices, requiring these documents to be written in Portuguese, except in exceptional cases authorised by Infarmed.
• Supervision and sanctioning regime: as is typical of an implementation, the new law also establishes its own supervision and sanctioning regime, while maintaining the amounts of fines already provided for in the Clinical Research Law (which may, in the case of legal persons, amount to €750,000).
• Fees: finally, the intention to issue a new fee regime, to be set by ordinance, is highlighted, with Ordinance 63/2025, of March 5, remaining in force until then.

Despite these changes, it is important to note that the responsibility of the sponsor and the principal investigator, the need to take out insurance and the obligations to provide the device and auxiliaries free of charge, before and after the conclusion of the study, remain in force, without material changes.

Moreover, it is also important to note that, with this new law, performance studies with in vitro diagnostic devices now benefit from a robust national clinical research regime that is very close to what was already applicable to studies with medical devices and medicinal products.

Entry into force and Transitional Regimes

The law enters into force 30 days after publication, that is, on January 21, 2026.

It should be noted, in any case, that the law provides for a transitional regime: clinical investigations that have been initiated before the application of the MDR and IVDR, i.e., before 26 May 2021 and 26 May 2022, respectively, continue to be governed by the Clinical Research Law.

This transitional regime does not apply, however, to the notification of serious adverse events and defects in medical devices, which must be governed by the MDR and the new law.