It has been just over three years since the respective notification procedure to the European Commission (reported here), the Portuguese Government approved Decree-Law no. 29/2024 of 5^th April, ensuring the implementation in the internal legal order of the Medical Devices Regulation (MDR).

The Decree-Law sets out relevant rules for the medical devices sector, including:

• the identification of competent authorities and their powers; 
• activities relating to devices (manufacturing, custom manufacturing, manufacturing and use by and in health institutions, use, codification, distribution, marketing, and advertising);
• notified bodies;
• surveillance;
• common provisions concerning general obligations;
• inspection and supervision rules, and penalty regime applicable in the event of non-compliance.

The following provisions should be highlighted:

1. Article 11, about information on implantable devices, establishes as mandatory for any organization, public or private, that uses implantable devices, to make available to the patient or consumer the information referred to in Article 18(1) of the MDR.
    
2. Article 14, on codification, determines that the presentation and register of the device code are necessary for the acquisition, use, identification, and characterisation of medical devices used by entities of the National Health Service, in terms to be defined by order of the member of the Government responsible for the health area. The attribution of the device code, in electronic format, is Infarmed’s responsibility and derives from the references notified in its databases[1]. 
    
3. Article 15, on loan and consignment, provides that such activity is only possible without the transfer of property of the medical device; it can only be carried out by organisations that have implemented a Quality Management System following EN ISO 13485; is subject to a written agreement; traceability must be guaranteed, and records must be kept of the operations carried out.
    
4. Article 31, on derogation from conformity assessment procedures, provides that Infarmed may, exceptionally, authorise the placing on the market or putting into service in the national territory of specific devices that have not yet been subject to conformity assessment procedures, but whose use contributes to public health or the safety or health of patients.
    
5. Article 38 sets out general duties for anyone who manufactures, stores, markets, displays for sale, imports, exports, transports, makes available, distributes, or uses in the provision of healthcare, or in any way transacts with medical devices.
    
6. Article 40, on the language of documents, elements, and information, provides that they must all be presented in Portuguese or be accompanied by an official translation unless expressly waived by Infarmed. The same obligation applies to the labelling, instructions for use, and advertising material for the device, implant card, and other information to be made available by the manufacturer, including graphical interface.
    
7. Article 41 establishes that the technical documents should be kept for 10 years [or 15, in the case of implantable devices] after starting to use the device, and be available for consultation.
    
8. Article 43 provides that Infarmed may adopt specific measures concerning a particular device, category, or group of devices, to guarantee the protection of people’s health, safety, or compliance with the MDR. This includes the issuance of guidelines on conditions of use, or special accompanying measures, including the warnings necessary to avoid risks to public health arising from the use of medical devices. As per Article 49(1), any decisions that restrict, condition, or prohibit the placing on the market of devices must be substantiated and notified to their addressees.

As anticipated within the scope of the 2015/1535 notification procedure of the draft version of this decree-law, the reprocessing and further use of single-use devices, notably in healthcare institutions, as well as in entities linked to the healthcare network or their subcontractors, set up as hospitals, hospital centres or healthcare establishments duly registered for this purpose with the Health Regulatory Authority is permitted in Portugal, per the conditions and requirements contained in Articles 16 to 23. The main rules on this matter focus on obligations, notification requirements and subcontracting, and the definition of prohibited reprocessing activities.

The effective impact of this permission, however, may be less than expected considering the reprocessing prohibition imposed on several types of medical devices (Article 22) and the prohibition to make available or reuse medical devices reprocessed in another EU Member-State or third country (Article 23).

As concerns advertising of medical devices, Article 52(5) establishes that the current rules (as provided in Decree-Law no. 145/2009 of 17^th June, as amended) remain in force, until their revision.

The same applies to in vitro medical devices [Article 52(6)] where, until Regulation (EU) 2017/746 is implemented, the rules provided in Chapter XVII from Decree-Law no. 145/2009 remain effective.

Moreover, until EUDAMED is implemented and operational, some provisions of Decree-Law no. 145/2009, as listed in Article 52(2), remain applicable to manufacturers, authorised representatives, and distributors. 

Without prejudice to the exceptions provided in Decree-Law 29/2024 and exemplified above, the new legal regime is effective from the 4^th of July 2024.

Resources: 

[1] Infarmed provides information on the registration of medical devices notified by manufacturers/representatives and/or wholesale distributors, as part of compliance with the applicable legal requirements, accessible at https://www.infarmed.pt/web/infarmed/pesquisa-dispositivos