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Software enquanto dispositivo médico: enquadramento regulamentar
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| Projeto de pós-graduação_40902 | 824.01 KB | Adobe PDF |
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Abstract(s)
O Regulamento Europeu dos Dispositivos Médicos (RDM) veio trazer novas exigências a todos os dispositivos médicos, atualmente, disponibilizados no mercado, nos quais se incluem os softwares para uso médico. Urge, pois, regulamentar quer a sua utilização, quer a sua comercialização. O regulamento para os dispositivos médicos 2017/745 exigiu uma abrangência da definição de dispositivo médico (DM) para sistemas de software isolados a fim de realizar uma previsão e um diagnóstico médico. Assim, esta alteração de paradigma permitiu um desenvolvimento de sistemas de software mais dinâmicos e de menos dimensão e complexidade.
Contudo, para colocar qualquer dispositivo médico no mercado, o fabricante terá que garantir a conformidade do produto, de acordo com as diretivas europeias aplicáveis. Um dos requisitos para colocação de um dispositivo médico no mercado é a exigência de uma avaliação clínica, nomeadamente, na realização de uma investigação clínica sobre o produto em questão e, posteriormente, a sua comprovação. Em Portugal, a realização de investigação clínica com dispositivos médicos necessita da aprovação da Autoridade Competente – INFARMED I.P. – e da Comissão de Ética para a investigação clínica. Este trabalho visa apresentar o quadro legal que regula os dispositivos médicos e a saúde digital, apresentando um guia para a classificação, qualificação e aprovação de softwares enquanto dispositivos médicos. Visa, ainda, fazer uma crítica sobre as dificuldades e as oportunidades que o Regulamento Europeu dos Dispositivos Médicos aportou à admissão ao mercado destes produtos, bem como fazer uma reflexão sobre a evolução dos mesmos, nomeadamente, no que concerne aos wearables e ao impacto do uso de algoritmos de machine learning e inteligência artificial.
The European Medical Devices Regulation has introduced new requirements for all medical devices currently available on the market, including software for medical use. There is therefore an urgent need to regulate both their use and their marketing. The medical devices regulation 2017/745 required the definition of a medical device to be extended to stand-alone software systems in order to carry out medical forecasting and diagnosis. This paradigm shift has allowed for the development of more dynamic software systems that are smaller and less complex. However, in order to place any medical device on the market, the manufacturer will have to ensure that the product complies with the applicable European Directives. One of the requirements for placing a medical device on the market is the need for a clinical evaluation, namely carrying out a clinical investigation into the product in question and then verifying it. In Portugal, clinical research on medical devices requires approval from the Competent Authority – INFARMED I.P. – and the Ethics Committee for clinical research. This paper aims to present the legal framework governing medical devices and digital health, presenting a guide to the classification, qualification and approval of software as medical devices. It also aims to critique the difficulties and opportunities that the European Medical Devices Regulation has brought to the admission of these products to the market, as well as reflecting on their evolution, particularly with regard to wearables and the impact of the use of machine learning algorithms and artificial intelligence.
The European Medical Devices Regulation has introduced new requirements for all medical devices currently available on the market, including software for medical use. There is therefore an urgent need to regulate both their use and their marketing. The medical devices regulation 2017/745 required the definition of a medical device to be extended to stand-alone software systems in order to carry out medical forecasting and diagnosis. This paradigm shift has allowed for the development of more dynamic software systems that are smaller and less complex. However, in order to place any medical device on the market, the manufacturer will have to ensure that the product complies with the applicable European Directives. One of the requirements for placing a medical device on the market is the need for a clinical evaluation, namely carrying out a clinical investigation into the product in question and then verifying it. In Portugal, clinical research on medical devices requires approval from the Competent Authority – INFARMED I.P. – and the Ethics Committee for clinical research. This paper aims to present the legal framework governing medical devices and digital health, presenting a guide to the classification, qualification and approval of software as medical devices. It also aims to critique the difficulties and opportunities that the European Medical Devices Regulation has brought to the admission of these products to the market, as well as reflecting on their evolution, particularly with regard to wearables and the impact of the use of machine learning algorithms and artificial intelligence.
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Keywords
Dispositivos médicos Software Saúde digital Regulamento dispositivos médicos Medical devices Software Digital health Medical device regulation