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How to obtain the CE marking for personal protection equipment (PPE)

PPE is a class of products with essential relevance in the management of the COVID-19 emergency: this includes filtering masks and shields, just to mention some.

In this article, we will discuss what is required from manufacturers to obtain the CE marking of PPE according to Regulation EU 2016/425. This will allow other business operators, usually involved in the marketing process, to have clearer information on some essential aspects of the sale of these products.

We should start by saying that, first of all, a PPE should comply with the essential health and safety requirements specified in the Regulation.

The compliance of PPEs with the legal requirements shall be ascertained by an appropriate conformity assessment that can include the intervention of a Notified Body, depending on which of the three risk categories of Regulation EU 2016/425 the equipment belongs to.

The manufacturer is bound to draft and keep the relevant technical documentation; this specifies the means used by the manufacturer to ensure the conformity of the device, and it should generally include at least the following:

  • description of the PPE and its intended use;
  • An assessment of the risks the PPE is intended to protect from;
  • A list of essential health and safety requirements applicable to the PPE;
  • Drawings, projects and manufacturing designs of the PPE and its components with any relevant descriptions;
  • A reference to harmonised norms or other technical specifications that were applied for the PPE design and manufacturing;
  • Results of any design calculations, inspections and tests carried out to check its conformity;
  • Reports on the tests carried out to check the conformity of the PPE to the applicable essential health and safety requirements, and to establish the relevant protection class, if required;
  • A description of the means used by the manufacturer during the PPE manufacturing to ensure the conformity to the design specifications;
  • Copy of the instructions and information of the manufacturer.

Along with the above, it is essential that the manufacturer drafts a declaration of EU conformity complying with the information content clarified in Regulation EU 2016/425.

The ready availability of such complete and compliant documentation allows the manufacturer to give evidence of the activities carried out to make the device comply with the legal provisions. This is particularly important if we consider the recent provisions for the waiver of validation of the PPEs by the National Institute for Insurance against Accidents at Work (INAIL), requiring the supply of materials usually part of the technical dossier according to Reg. EU 2016/425.

Of course, in the marketing phase the PPE will include all information provided by the manufacturer on the device or the relevant labelling and use handbooks.

The subjects importing or distributing the PPE in the EU area should verify the performance of the assessment procedure by the manufacturer. For instance, type FFP2 and FFP3 filtering half-masks fall into Category III, for which an assessment with the intervention of Notified Body is provided for. In case this assessment has a positive outcome, this body will provide to the release of the appropriate certificates of conformity and will authorise the manufacturer to include the CE marking in the device.