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.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

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

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »