MHRA - Transparent Facemasks

20th April 2021

Transparent face masks

If you make a clear surgical/medical face mask intended to protect patients, they are Class I medical devices and must meet the design and safety requirements as above.

Transparent masks may only state that they are Type IIR when they have met the requirements of the EN 14683:2019 standard in full. If only partial compliance is achieved then they must not be labelled or advertised as Type IIR.

The UK Government have recently published a new technical specification specifically relating to transparent face masks. Manufacturers of transparent face masks should work towards this specification when bringing their product to market as a medical device.

More information on the transparent face mask technical specification.

Products incorrectly labelled or advertised will be subject to regulatory compliance action.

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