European Commission: European standards for medical supplies made freely available to facilitate increase of production
In the context of the Coronavirus crisis, the Commission is working with industry and Member States to maximise the availability of masks, gloves, gowns and other medical supplies. Efforts include increasing production by existing manufacturers, facilitating imports and activating alternative ways of producing equipment.
Upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety.
The agreement dated March 29 has immediate effect. The 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing.
This initiative complements the Commission Recommendation on the conformity assessment and market surveillance procedures, which provides guidance to national bodies on allowing non CE-marked personal protection equipment that comply with the necessary health and safety standards to enter the EU market within the context of the Coronavirus.
The standards are available for free download from the websites of CEN national members.
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