The importance of medical devices in preventing and combating SARS-CoV-2 and cooperation between national regulators, academy and industry - Perspectives from the Portuguese reality

• Main Author: Isabel Maria Martins Portugal de Abreu
• Format: Article
• Language: English
• Published: ALIES - Associação Lusófona para o Desenvolvimento da Investigação e do Ensino das Ciências da Saúde 2020-12-01
• Series: Journal Biomedical and Biopharmaceutical Research (BBR)
• Subjects: infarmed; medical devices legislation; covid-19; sars-cov-2
• Online Access: http://www.alies.pt/BBR%20Editions/Vol-17-2-2020/bbr.17.2.240.pdf

In view of the scarcity of medical devices necessary to combat the outbreak crisis caused by the new SARS-CoV-2 coronavirus pandemic, an exceptional regime regarding applicable device conformity assessment procedures and market surveillance was established through Recommendation (EU) 2020/403 of the European Commission of 13 March. This was adopted by Portugal through the publication of Decree-Law no. 14-E / 2020 of 13 April. Many guidelines were issued during the pandemic by INFARMED and with the cooperation of other national entities (Ministry of Economy, Ministry of Science, Technology and Higher Education, national Industry and General Directorate of Health) to support medical device manufacturers and importers. It is important that these guidelines are reflected in the development of the Portuguese medical device industry in order to promote its international recognition and to ease access to other medical markets. A detailed analysis of all variables here included in this opinion article, together with some proposals, aims to promote a national strategic vision in the area of the development and production of medical devices, in order to enhance ideas and gains that resulted from these responses to the crisis, serving for future analysis to be published in due course.