Class Medical Devices

The medical device sector is of high technical-scientific and regulatory complexity. Its use is increasingly frequent, encompassing a wide range of products that have come to assume a key role in the health system, with high economic value. The UC of medical devices will cover the technical - regulatory and technical - scientific aspects of the life cycle of the medical device, from concept to market, which support the guarantee of its safe use and the defense of public health. Through practical cases will be developed the ability to analyze, interpret knowledge and facts with application in problem solving.

Not applicable

Regulation of Health Technologies and Medical Devices: Regulatory Framework; Research and Development, Technical-Scientific Assessment; Risk classes and border demarcation; Essential pre and post market requirements; European Standards and CSs; Pre-clinical, clinical /Clinical and functional performance investigation; Technical documentation; Pre- and post-market Conformity Assessment: and Procedures; Health economics in medical devices: Surveillance, Post-marketing monitoring and market surveillance; Registration of medical devices, Coding, Traceability and Unique Identification of medical devices; Economic Evaluation and SINATS. Market access: Acquisition of medical devices by the NHS; Transparency and access to information about medical devices.

In this curricular unit, the Team-based learning (TBL) methodology is used, with the realisation of tasks in small groups, allowing the development of the ability to analyse and apply theoretical and practical concepts.

REGULAMENTO (UE) 2017/745 DO PARLAMENTO EUROPEU E DO CONSELHO de 5 de abril de 2017            https://eur-lex.europa.eu/legal-content/PT/TXT/?uri=CELEX%3A32017R0745 REGULAMENTO (UE) 2017/746 DO PARLAMENTO EUROPEU E DO CONSELHO de 5 de abril de 2017             https://eur-lex.europa.eu/legal-content/PT/TXT/?uri=CELEX%3A32017R0746 http://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos/monitorizacao-do-mercado-de-dispositivos-medicos http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm    https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en