IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany

Mariana Madureira

Senior Officer, Health Products Directorate, INFARMED

Mariana joined INFARMEDĀ in 2002, as a Quality assessor at Operational Unit of Technical and Scientific Evaluation of Human Medicines. One year later she joined the Medical Devices team, field of expertise she has embraced so far, despite other different roles she held within the organisation between 2013 to 2017, such as Adviser to the Management Board and at the Quality and Planning Office.

Currently, at this authority she has a role of project manager (within the scope of the implementation of medical devices regulations) and market surveillance assessor at Health Products Directorate. Given her experience, she is also providing support to regulatory and scientific advice activities. Mariana is one of national expert for Joint Assessment of Notified Bodies.

Mariana represents INFARMED at different European working groups, in particular the New Technologies WG (MDCG NT WG), contributing as one of the co-chairs. She is member of the Competent Authorities for Medical Devices (CAMD) network and Medical Device Coordination Group (MDCG).

At international level, Mariana integrates the European delegations for the subgroups of International Medical Device Regulators Forum (IMDRF) on Personalized Medical Devices and on Artificial Intelligence Medical Devices.