The pursuit of medical device distribution activities within Portuguese territory is governed by Regulation (EU) 2017/745 and by Decree-Law No. 29/2024, which lays down the rules applicable to economic operators involved in the manufacture, importation and distribution of medical devices in Portugal.
The distribution activity is only permitted by medical device distributors that cumulatively meet the following requirements:
- The appointment of a technical responsible person who ensures that the activity is carried out in compliance with the applicable legal and regulatory obligations.
- The availability of suitable premises and equipment capable of ensuring appropriate conditions for the storage, preservation and distribution of devices, thereby safeguarding their quality, performance and safety.
Obligations of Medical Device Distributors
Natural or legal persons carrying out medical device distribution activities are required, inter alia, to submit to INFARMED, I.P., in electronic format and for the purposes of codification and regulatory supervision, detailed information regarding the devices distributed, namely:
A list of the devices, including their name, brand, model, reference(s) assigned by the manufacturer, nomenclature code, description and intended purpose, risk class, identification of the notified body (where applicable) and UDI identifier (UDI-DI), in particular for implantable devices:
- Identification of the manufacturer or, where the manufacturer is not established within the European Union, of the authorized representative.
- The labelling and instructions for use of each device.
- Any amendments or updates to the mandatory notification elements, including the date from which the distribution of a specific device ceases.
- Distributing companies or foreign manufacturers intending to operate in Portugal must notify INFARMED in advance of the commencement of distribution activities.
Such notification must be submitted at least 60 days prior to the start of the activity and shall be filed by a technical person responsible with appropriate qualifications. If INFARMED does not issue a decision within this period, the entity shall be deemed authorized to commence the activity lawfully.
Essential Requirements for the Marketing of Medical Devices
Only medical devices that cumulatively comply, inter alia, with the following requirements may be placed on the Portuguese market:
- Identification of the device.
- Name and address of the manufacturer.
- Batch number or serial number.
- Expiry date, where applicable.
- Necessary warnings and precautions.
- Valid CE marking.
- Conformity assessment carried out in accordance with the applicable legislation.
CE Marking and Information in the Portuguese Language
CE marking constitutes an essential requirement for the marketing of medical devices in Portugal. It must be visible, legible and indelible on the device, on its packaging and on the instructions for use, and must be accompanied by the identification number of the notified body responsible for the conformity assessment.
Belzuz Abogados, S.L.P. – Branch in Portugal is available to provide comprehensive legal advice in the management of these procedures, ensuring that both domestic and foreign companies comply with all legal requirements applicable to the marketing of medical devices in Portugal, facilitating market access and minimizing legal and regulatory risks.