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European Commission Guidance for manufacturers of medical equipment and material

  • European Commission

To address the Coronavirus outbreak and to ramp-up overall production of personal protective equipment, the European Commission has already made available relevant European harmonised standards to interested companies, as well as revised harmonised standards that allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general.

Recently, the European Commission announced guidance in three further areas to assist manufacturers in increasing the output of essential medical equipment and material: 

(1) The production personal protective equipment such as masks
(2) Leave-on hand cleaners and hand disinfectants
(3) 3D printing

These documents can assist manufacturers and market surveillance authorities in ensuring that these products are effective and comply with necessary safety standards.

For further information, please refer to the European Commission Website © European Union, 1995-2020.

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