Guidelines concerning personal protective equipment and medical devices

Commission Recommendation (EU) 2020/403 within the context of the COVID-19 threat

On 16.3.2020, the Commission published in the Official Journal L 79 I (page 1) a recommendation relating to the provision of specific personal protective equipment - in short: PPE - (face masks, protective gloves, protective coveralls or eyewear protection) and specific medical devices (surgical masks, examination gloves and certain types of gowns) to assist in combating the COVID 19 pandemic. With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand.

Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users’ health and safety.

To flesh out this recommendation, the Commission published three guidelines on 30.3.2020

» Official Journal

» Read more

Published on 09.04.2020
Category: Fokus Medical Devices, Compliance

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