IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION

On April 5, 2024, Decree-Law no. 29/2024, with effect from July 4, 2024, defining the provisions applicable to economic operators, healthcare institutions that manufacture and use devices in their respective facilities, as well as the rules applicable to use and traceability of devices, the designation and supervision of the activities of notified bodies, surveillance and market surveillance, also including conditions and requirements that the reprocessing and use of reprocessed single-use devices must comply with in the national territory.