Aplicação do Novo Regulamento Europeu de dispositivos médicos para diagnóstico in vitro em Portugal
Desde o dia 26 de maio de 2022, são aplicáveis as novas regras do RDIV. Em consequência, alguns requisitos nacionais sofrerão alterações ou serão substituídos por regras europeias.

Desde 26 de maio de 2022 são aplicáveis a grande maioria dos novos requisitos regulamentares estabelecidos no Regulamento Europeu de dispositivos médicos para diagnóstico in vitro (RDIV), que vem revogar a Diretiva 98/79/CE e o Decreto-Lei nacional 189/2000, nas matérias abrangidas pelo RDIV.

Além de pretender acompanhar o progresso dos conhecimentos científicos e tecnológicos do setor, esta atualização regulamentar pretende assegurar o mais alto nível de proteção da saúde dos doentes, profissionais de saúde e outros utilizadores destes produtos e responder às preocupações de segurança.

Ao contrário da anterior Diretiva 98/79/CE, o RDIV tem aplicabilidade direta em Portugal, não sendo necessária a sua transposição para o direito nacional. Assim sendo, fabricantes, mandatários, importadores e distribuidores devem dar cumprimentos aos requisitos do RDIV a partir da sua data de aplicação.

Não obstante a aplicação direta do RDIV, até à operacionalização da base de dados europeia de dispositivos médicos (EUDAMED), mantêm-se em vigor as regras nacionais relativas às seguintes obrigações:

– Registo de dispositivos médicos para diagnóstico in vitro por fabricantes, mandatários e distribuidores por grosso, conforme os procedimentos de registo na plataforma SIDM do INFARMED;

– Notificação da atividade de fabrico e de distribuição pro grosso conforme os procedimentos de registo na plataforma Licenciamento+ do INFARMED (cuja revisão se encontra em curso);

– Notificação de incidentes graves e ações corretivas de segurança ao INFARMED, conforme procedimentos vigentes, mas de acordo com os prazos definidos pelo RDIV.

O diploma que assegura a execução do RDIV na ordem jurídica interna, nas matérias cuja competência legislativa foi atribuída a Portugal, encontra-se em fase final de elaboração, devendo ser colocado em breve em circuito legislativo.

Referências:

Circular Informativa INFARMED, I.P. N.º 054/CD/550.20.001 de 26/05/2022

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