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11 November 2020
The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period.
There have already been multiple initiatives to combat the pandemic, particularly by converting production lines to manufacture PPE, MDs and other essential products (eg, biocides).
In view of this and the circumstances of the pandemic, Decree-Law 14-E/2020 of 13 April 2020 was published to establish exceptional and temporary arrangements for the manufacture, import, placement and availability on the market of MDs and PPE. The measures aim to prevent the spread of COVID-19 by setting out the conditions under which it is possible to derogate from or adapt the procedures to assess compliance with the legally imposed health, safety and performance requirements.
These exceptional arrangements apply only to:
As regards the import of MDs and PPE, it is provided that:
MDs and PPE can be manufactured, without CE markings, provided that the manufacturer complies with the health, safety and performance rules indicated for this purpose by INFARMED (for MDs) and ASAE (for PPE). Manufacturers must also submit documentary proof of compliance with the essential health and safety requirements applicable to the products in question.
As regards the requirements for the manufacture, import and marketing of masks for social use (textile articles), Decree-Law 14-E/2020 does not define specific rules, but refers only to the technical requirements that are published by the economic and health authorities.
As a result of this legislation, in April 2020, INFARMED and ASAE published a set of additional rules on procedures for the manufacture, import and marketing of MDs, PPE and social-use masks on their websites. These rules essentially address the equivalence of applicable international technical rules and labelling.
As to placing and making items available on the market, when the import or manufacture is carried out in accordance with what is set out above, and provided the other requirements for placing products on the market are met:
Lastly, while the original version of Decree‑Law 14-E/2020 aimed to facilitate the reorientation of companies' production structures towards the products needed for the pandemic, it made no changes to industrial licensing requirements.
In response to this problem, Decree-Law 36/2020 amended Decree-Law 14-E/2020 by establishing a simplification of procedures for industrial licensing of MDs, PPE, ethyl alcohol and other biocide disinfectant products.
The authorisations resulting from these simplified procedures, which aim to make it easier to place on the market products to prevent the spread of the COVID-19 pandemic, are exceptional in nature and expire 30 days after the repeal of Decree-Law 14-E/2020.
Finally, both Decree-Law 14-E/2020 and the amendment introduced by Decree-Law 36/2020 have retroactive effect as from 13 March 2020 to ensure compatibility with the law containing measures to expedite the production and marketing of products necessary to prevent the spread of COVID-19.
For further information on this topic please contact Eduardo Nogueira Pinto, Eliana Bernardo or Rúben do Carmo Pereira at PLMJ by telephone (+351 213 197 300) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). PLMJ website can be accessed at www.plmj.com.
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