Portuguese publish devices law
This article was originally published in Clinica
Executive Summary
The Portuguese law implementing the EU's Medical Devices Directive was published on October 23rd. INFARMED, which has the Competent Authority role for non-active medical devices, will have overall responsibility for vigilance, although it will work in close co-operation with the other Competent Authority, INSA, which is responsible for active medical devices. Vigilance reports should be sent to Dr Aranda Silva at INFARMED. (Portugal is the only country to have split its Competent Authority in this way.)