Implementation of the Medical Devices Regulation

The new legal framework for medical devices was established by Decree-Law 29/2024 of April 5 that ensures the implementation of Regulation (EU) 2017/745 on medical devices (the “MDR”). It foresees the rules applicable to economic operators and health institutions that manufacture and use devices in their facilities, as well as the rules applicable to the use and traceability of devices, the designation and supervision of the activities of notified bodies, market surveillance and control, and the applicable sanctions for non-compliance.

In comparison to the previous regime, the following new features stand out:

• Medical device manufacturing: The manufacturing of custom-made devices and the manufacturing and use in health institutions are now subject to a specific regime that provides higher safety standards compared to the previous regime. In particular, the regime for manufacturing and use of medical devices in health institutions is now subject to a greater number of obligations: (i) implementing a Quality Management System; (ii) implementing a system for recording and analyzing the experience gained from clinical use of the device; and (iii) submitting to Infarmed the reasons justifying these activities, where the specific needs of the target patient group cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market.

• Responsibility of health institutions: Health institutions are now subject to obligations similar to those of the industry, particularly regarding devices manufactured and used in these institutions, and consequently have greater responsibility under this new regime. The supervisory powers of Infarmed are extended and now assumes responsibly for overseeing health institutions on these matters.

• Reprocessing: Given the flexibility that the MDR provides to Member States regarding the reprocessing of single-use devices, the new regime provides for admissibility of these activities and determines the specific obligations for entities that perform them to ensure high safety standards in these procedures.

• Obligations of distributors: The obligations of distributors are generally aligned with the MDR and the previous regime under Portuguese law, in spite of some changes regarding the device registration process, which will now be carried out through a common European platform: EUDAMED. In any case, for the time being, this change will not have any impact on the procedures prior to marketing a medical device. Indeed, Infarmed has already clarified that, while EUDAMED is not fully operational, the notification of medical devices to the authority should continue to be carried out through the Medical Devices Information System.

• Provision of medical devices on consignment and loan: The provision of medical devices on consignment and loan is now subject to specific rules. Entities that carry out these activities must (i) implement and maintain a quality assurance system; (ii) have a written contract signed to support these activities, and (iii) ensure traceability of the products and maintain all records of operations carried out. It also establishes additional obligations to safeguard situations where these devices are subject to reprocessing and subsequent reuse.

In summary, the new regime reveals the legislator’s clear intention to change the landscape of the manufacture, marketing and use of medical devices, extending its rules and obligations to health institutions involved in manufacture and use of medical devices.

Although the Decree-Law was published and came into force on April 6, 2024, it will take effect 90 days after its publication.