Simplification of conformity procedures for CoViD-19 Pandemic-relevant products in Portugal
As a response to the Covid-19 pandemic, and following the Commission’s Recommendation 2020/403, published in March, the Portuguese government has published legislation aimed at increasing the availability of Covid-19 pandemic-relevant products.
In April, a decree-law established special and transitory rules to simplify and speed up the manufacture, import, placing and availability of medical devices ⎯ MD and personal protection equipment (PPE) ⎯ on the Portuguese market, while ensuring that said products continue to provide adequate levels of protection for the health and safety of users.
Usually, for MD and PPE to be placed in the EU market, manufacturers must affix the CE marking on the products. This can only happen after the conformity assessment procedure applicable to their category, as per the respective EU legislation, is concluded.
However, the Portuguese decree-law allows the placement of non-CE marked MDs and PPE necessary to prevent the spread of SARS CoV-2 on the Portuguese market. Nevertheless, these non-CE marked MD and PPE must prove, through documentation and certificates, their conformity to the health, safety and performance requirements, as per the applicable normative standards referred in a list elaborated by the respective competent authorities (INFARMED for MD, and ASAE for PPE). If the non-CE-marked products claim conformity through normative standards other than those mentioned in said lists, importers must await the respective authority’s favorable decision, in order to place them on the Portuguese market.
In July, the decree was updated and now includes social use masks in the list of products; and establishes a simplified licensing procedure for manufacturing sites of medical devices, PPE, ethyl alcohol, and disinfectant biocidal products.
Ana Rita Falcão
RA Junior Consultant
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