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COVID-19: Preventing delays for protective equipment

24.3.2020

PR(20)09

EN | NO

New recommendations from ESA accommodate swifter placing of medical devices and personal protective equipment (PPE) on the market.

Existing EEA law requires conformity assessments and marking of medical devices and personal protective equipment before such products can be imported and sold on the EEA market. This is a time-consuming process.

Exceptional times

Therefore, ESA has today adopted a Recommendation on conformity assessment and market surveillance procedures in the context of the COVID-19 threat. An equivalent recommendation has been issued by the European Commission.

In these exceptional times, ESA recommends a series of measures in order to accommodate the swifter placing on the market for such products needed in a COVID-19 context.

Quicker assessments

The measures include suggestions on procedures for quicker conformity assessments for new PPE products and a recommendation to the EEA EFTA States to consider the possibility of derogations from standard conformity assessment procedures for medical devices, as provided for in the relevant EEA legal Act.

ESA also recommends prioritising certain national market surveillance measures, including focus on non-compliant PPE and medical devices raising serious risks.

For further information, please contact:

Øystein Solvang
Head of Communications
mob. +32 490 57 63 53




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