COVID-19: conformity assessment and market surveillance procedures

Tuesday, 24 March 2020 15:11 Market Surveillance
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The COVID-19 pandemic and the rapid spread of the virus in Europa has greatly increased the need for personal protective equipment (PPE) such as masks, gloves, protective suits or goggles and medical devices such as surgical masks, examination gloves and certain types of gowns.

This has led to strong pressure on the production chain of certain types of PPE, such as disposable face masks. Furthermore, as the health and safety of EU citizens is the highest priority, it is of fundamental importance to ensure that the appropriate PPE and medical devices are made available quickly.

For this reason, the European Commission adopted Recommendation (EU) 2020/403 of 13 March 2020 in order to ensure the availability of PPE and medical devices to provide adequate protection in the context of the COVID-19 outbreak. The Commission invites economic operators throughout the supply chain as well as notified bodies and market surveillance authorities to implement all measures at their disposal to support efforts to ensure that the supply of PPE and medical devices throughout the EU market meets the ever-increasing demand. However, these measures should not have a negative effect on the level of health and safety and the stakeholders should ensure that any PPE or medical device placed on the EU market continues to provide an adequate level of protection for the health and safety of users.

In this context, the application of the conformity assessment procedures provided for in Regulation (EU) 2016/425 and Directive 93/42/EEC which will soon be replaced by Regulation (EU) 2017/745 is of fundamental importance; in fact the disposable and reusable masks for protection against particulate hazards, disposable and reusable overalls, gloves and goggles, used for prevention and protection against biological agents such as viruses, are products that fall within the scope of Regulation (EU) 2016/425 while surgical masks, examination gloves and certain types of gowns are products falling within the scope of Directive 93/42/EEC and Regulation (EU) 2017/745.

44 Tuesday, 24 March 2020 20:51

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