Decree Law No. 14-E/2020
- Issuer: Presidency of the Council of Ministers
- Diploma Type: Decree Law
- Number: 14-E/2020
- Pages: 86-(2) a 86-(5)
Summary in plain english
This decree-law establishes special and transitory rules regarding the manufacture, import, placing and availability on the national market of:
- medical devices for human use (MD), for example, swabs;
- personal protection equipment (PPE), e.g. surgical masks.
Given the public health emergency of international scope, declared by the World Health Organization on 30 January 2020, as well as the classification, on 11 March 2020, of the COVID-19 disease as a pandemic, the Government has been approving a set of extraordinary and urgent measures in several matters.What is going to change?
The manufacture, import, marketing and use of MD and PPE must comply with the rules for assessing conformity with health and safety requirements required by law.
If they comply, they will be identified with the CE mark and the EU declaration of conformity will be issued.
During the COVID-19 outbreak, these rules may be adapted or abolished by determinations to be defined by INFARMED and ASAE.What advantages does it bring?
This decree-law simplifies and speeds up the procedures necessary for the manufacture, import, marketing and use of MD and PPE, while still ensuring that all MD and PPE placed on the market continue to provide adequate levels of protection for the health and safety of users.
Prevents contamination by the new coronavirus (SARS-CoV-2).When does it enter into force?
This decree-law enters into force on 14 April 2020 and takes effect on 13 March 2020.
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