Commission harmonises standards for face masks, gowns

In the context of the EU response to coronavirus outbreak, the Commission adopted decisions on harmonised standards, which will allow manufacturers to place on the market high performing medical protective devices.

The revised norms relate to critical devices such as medical face masks, surgical drapes, gowns and suits. They also cover washer-disinfectors and sterilisers.

The revamped standards will facilitate a faster and less expensive conformity assessment procedure with products with a pivotal role in the current situation with the pandemic.

With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market, Stella Kyriakides, EU Commissioner for Health explained accenting that this equipment is fundamental for the health professionals “the brave and resilient women and men at the front line - to keep saving lives”.

Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.

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