FFP2 and FFP3 masks are classified as Category III PPE because they provide protection against serious or potentially irreversible risks, including exposure to airborne biological agents.

For this reason, they require a certification process that includes testing in accordance with the EN 149 standard, the EU Type Examination (Module B), and, for the purpose of placing the product on the market, a conformity assessment leading to the issuance of a Module C2 Test Report or a Module D Certificate.

Proper classification requires a technical assessment of the risk, the intended conditions of use, and the product’s characteristics, as this determines whether a Notified Body is involved and which certification modules set forth in the Regulation apply.

Our team of experts is available to analyze the product’s characteristics and provide all the necessary assistance to determine the most appropriate certification path in the shortest possible time.

In general, the required documentation includes the Technical File in compliance with Regulation (EU) 2016/425, the User Information Sheet, and any available test reports—all of which are essential for properly initiating the certification process. Our goal is to provide you with precise support to ensure that your application is approved as efficiently as possible.

If a PPE model has variants in color, materials, or components, it is necessary to assess whether these differences could affect safety performance and compliance with the requirements of the applicable standards. Depending on the characteristics of the variants, the technical tests required to demonstrate that the entire product range remains in conformity with the certified type and the requirements of Regulation (EU) 2016/425 are identified.
A proper technical assessment of the variants allows for a consistent definition of the certification process, avoiding unnecessary testing and ensuring a smooth certification process applicable to the entire range of PPE.

If a piece of PPE fails one or more laboratory tests, the result is documented in the test report and analyzed in relation to the applicable requirements and the reference standard.  A non-conforming result does not automatically lead to the termination of the process, but indicates the need to: identify the causes of non-conformity (e.g., materials, design, or performance), evaluate possible modifications to the product or its components, define the additional tests necessary to demonstrate updated compliance.

Only after passing the required tests is it possible to proceed with the conformity assessment process set forth in Regulation (EU) 2016/425. A structured management of test results ensures a smooth and consistent certification process, in compliance with applicable regulatory requirements.