Publication
Dispositivos médicos - enquadramento científico regulamentar no âmbito da nova diretiva europeia
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Abstract(s)
O Regulamento (EU) 2017/745 relativo aos dispositivos médicos entrou em vigor em maio de 2017, o que revogou a Diretiva 93/42/CEE de junho de 1993. Este novo Quadro Regulamentar Europeu manteve os princípios regulamentares básicos, promover elevados padrões de segurança e proteção da saúde e garantir o acesso atempado da inovação ao mercado.
Com base no princípio máximo de saúde e segurança do doente, o Conselho e o Parlamento Europeu adotaram, a 23 de abril de 2020, o Regulamento 2020/561, que alterou o Regulamento (EU) 2017/745 sobre os dispositivos médicos no que diz respeito às datas de aplicação de algumas das suas disposições. Este adiamento de um ano, veio com o objetivo de aliviar a pressão sobre as autoridades nacionais, os organismos
notificados, os fabricantes e outros intervenientes, que permite que estes se concentrem totalmente nas questões relacionadas com a pandemia do coronavírus (European Commission, 2016).
Devido a dificuldades no passado, especialmente em incidentes que causaram problemas de saúde pública, este Regulamento veio reforçar áreas relevantes, como a investigação clínica, a designação e supervisão das atividades dos organismos notificados, procedimentos de avaliação de conformidade, a vigilância e fiscalização do mercado. Além deste reforço era necessário aumentar o poder de rastreabilidade em toda a cadeia de valor do dispositivo médico, possivelmente até ao doente se necessário.
The Regulation (EU) 2017/745 on medical devices took effect on May 2017, which revoked the Directive 93/42/CEE of June 1993. This new European Regulatory Frame kept the basic regulatory principles, promoting high standards of safety and health protection, and to ensure the early market access to innovation. In regard to the main principles, patient health and safety, the Council and the European Parliament adopted, in April 23 of 2020, the Regulation 2020/561, which changed the application dates, some of its provisions, from the Regulation (EU) 2017/745 on medical devices. This one year delay, came with the objective of relieving the national authorities, notified bodies, manufacturers and other actors, which allowed this parties to fully concentrate on coronavirus pandemic situation (European Commission, 2016). Due to past difficulties, especially the incidents that provoked public health issues, this Regulation came to reinforce relevant areas, such as clinic investigation, notified bodies designation and supervision, conformity evaluation procedures, and market surveillance and inspection. In addition to this reinforcement was necessary to increase the tracking capacities in all medical devices chain value, possibly until the patient if needed.
The Regulation (EU) 2017/745 on medical devices took effect on May 2017, which revoked the Directive 93/42/CEE of June 1993. This new European Regulatory Frame kept the basic regulatory principles, promoting high standards of safety and health protection, and to ensure the early market access to innovation. In regard to the main principles, patient health and safety, the Council and the European Parliament adopted, in April 23 of 2020, the Regulation 2020/561, which changed the application dates, some of its provisions, from the Regulation (EU) 2017/745 on medical devices. This one year delay, came with the objective of relieving the national authorities, notified bodies, manufacturers and other actors, which allowed this parties to fully concentrate on coronavirus pandemic situation (European Commission, 2016). Due to past difficulties, especially the incidents that provoked public health issues, this Regulation came to reinforce relevant areas, such as clinic investigation, notified bodies designation and supervision, conformity evaluation procedures, and market surveillance and inspection. In addition to this reinforcement was necessary to increase the tracking capacities in all medical devices chain value, possibly until the patient if needed.
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Medical devices Medical devices regulation New regulation medical devices