Decree-Law No. 14-E/2020, of April 13, establishes an exceptional and temporary regime for the design, manufacture, import, national commercialisation and use of medical devices (“MD”) for human use and of personal protective equipment (“PPE”) in Portugal. Said Decree-Law shall take effects as of March 13, 2020.
This exceptional and temporary regime was put in place to help tackle the current shortage of certified MD and PPE available in Portugal, being that the rapid dissemination of the new coronavirus has led to an exponential demand for said products.
As a rule, the design, manufacture, import, placing on the market and use of these products within the European area are subject to conformity assessment procedures. Where the conformity requirements are met, the CE marking is affixed to the products concerned. This assessment shall also be accompanied by surveillance procedures of compliance carried out by the competent authorities.
At the same time, there has been a mobilization of the national business fabric, as well as of the civil society, in a joint effort of fighting the COVID-19 pandemic. This has been possible with the redesign of the supply chains but also with the promotion of initiatives of collection and donation of such products. This increased supply shall be fed into the market without undue delays, otherwise, the efforts made by the industry stakeholders will not have the desired effects.
At a European level, the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat invites all economic agents throughout the supply chain, notified bodies and market surveillance authorities to arrange all measures needed to support the efforts aimed at ensuring that the supply of PPE and MD throughout the EU market will match the continuously increasing demand. However, these measures should not jeopardize the health and safety levels of the MD and PPE, placed on the EU market.
General Rule of Compliance
Decree-Law No. 14-E/2020 establishes a general rule of compliance, according to which:
1. The manufacture, import and placing on the domestic market of MD and PPE aimed at preventing the spread of COVID-19 shall follow the same conformity assessment procedures from which results the CE marking and the issuing of an EU declaration of conformity.
2. During the outbreak of COVID-19, the adaption or derogation from conformity procedures shall only be applicable to the products listed in said Decree-Law, namely, surgical masks to be used by health professionals, of single use and reusable; surgical masks for social use, of single use and reusable; single use gloves; protection goggles; visors and swabs.
Imports of Medical Devices and Personal Protective Equipment without CE marking
MD and PPE that are needed in the prevention of the dissemination of COVID-19 without the CE marking may be imported provided that these are accompanied by certificates or other documents demonstrating compliance with health, safety and performance rules adopted by other States, equivalent to those required by EU Regulations and in accordance with a list prepared by the INFARMED (the Portuguese Drug Authority) related with MD and by the ASAE (the Portuguese Food and Economic Security Authority) in relation to PPE.
Products that do not fulfil the abovementioned requirements shall present the necessary documentation for verification. These shall only be imported upon prior favourable decision from the INFARMED or the ASAE. This verification shall be requested by the importer and it shall be issued within four working days. The decision period may be extended once, for the same period, should it prove necessary to consult other entities.
The AT (Tax and Customs Authority) shall provide the INFARMED and the ASAE, in a fortnightly frequency, a list containing information on the quantity of products imported and their type, by reference to the import declarations submitted in each period.
Placing and Making Available on the Market Medical Devices and Personal Protective Equipment
Provided that the requirements for placing products on the market have been met, MD and PPE imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020 as well as masks for social use, may be made available:
(a) to health system units and other entities that have adequate sanitary supervision;
(b) for sale in pharmacies and authorised points of sale.
Provided that the requirements for placing products on the market have been met, respiratory protection semi-masks, social use masks and single-use gloves, imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020, may be freely placed on the market for sale in wholesale, retail outlets and in vending machines.
Caiado Guerreiro’s Health and Pharmaceutical Law team is available for any clarification on this matter.