Regulation (EU) 2017/745 aims to ensure the smooth functioning of the medical devices’ market throughout all European Member States.

‍
Now, INFARMED has just published the new Decree-Law No. 29/2024, which ensures the implementation of Regulation (EU) 2017/745 on medical devices, in Portugal.

‍
This law focuses mainly, but not exclusively, on the following issues:

• Manufacturing and use of devices in Healthcare Institutions;
• Designation, periodic reassessment and monitoring of Notified Bodies;
• General obligations of Distributors and requirements to fulfil;
• ‍Traceability of devices (including those reprocessed, manufactured in healthcare institutions, or made available on a loan or consignment basis);
• ‍Reprocessing and the use of reprocessed single-use devices;‍
• National Medical Device Surveillance System and contact points;
• ‍Inspections and monitoring (including administrative offences and fines)

‍

Until new legislative acts are published, certain topics, such as medical device advertising, will continue to be covered by the provisions outlined in Decree-Law No. 145/2009. To find out what these exceptions are, see article 52 of the new Decree-Law No. 29/2024.

Decree-law No. 29/2024 entered into force on 6th April 2024 and will take effect at the beginning of July 2024.

‍