Yuri Ceragioli -

Considering the COVID-19 pandemic there is a huge and increasing need of protective devices, protective masks in particular.

Protective masks such as FFP1 / FFP2 / FFP3 masks are classified as personal protective equipment (PPE) of category III according to the Regulation (EU)2016/425.

This implies:

  • a conformity assessment including an evaluation by a notified body authorized at European level;
  • the granting of an EC certificate by the notified body;
  • the CE mark symbol, reported on the mask and/or its labelling, followed by the numerical code of the notified body.

Due to COVID-19 emergency the Italian authority issued an emergency derogation procedure to allow the marketing of PPEs without CE mark, pending a preliminary fast evaluation by the national body “INAIL”.

The list of masks authorized according to this procedure is available at


Simple surgical masks are classified as class I medical device according to Directive 93/42/EEC.

This implies:

  • no conformity assessment with the involvement of a notified body;
  • a self-certified regulatory compliance by the manufacturer with the Declaration of Conformity CE mark symbol, reported on the mask and/or its labelling, not followed by any numerical codes.

FFP1 / FFP2 / FFP3 masks and surgical masks not compliant with the above do not meet the European requirements.

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