Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

Summary:

Recommendation adopted by the European Commission on 13 March 2020 relating to conformity assessments of Personal Protective Equipment (PPE) and certain medical devices, in the content of the coronavirus (COVID-19) outbreak.

Further information:

This Recommendation provides for two scenarios in which products may be placed on the market even if the conformity assessment procedures have not yet been finalised.

The European Commission invites all economic operators, as well as notified bodies and market surveillance authorities to deploy all measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices across the European Union (EU) matches the increasing demand. Even so, such measures should not have a detrimental effect on the overall level of health and safety.

• Primary Source

Official

European Commission: Q&A: Conformity assessment procedures for protective equipment https://ec.europa.eu/docsroom/documents/40521

European Commission: Q&A: Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)1 https://ec.europa.eu/docsroom/documents/40523

European Commission: Q&A: Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 https://ec.europa.eu/docsroom/documents/40522

European Commission: Press Release, 30/03/2020: Coronavirus: Commission issues questions and answers to help increase production of safe medical supplies https://ec.europa.eu/commission/presscorner/detail/en/ip_20_558

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