Yes. Before being placed on the European market, PPE must demonstrate compliance with the requirements of Regulation (EU) 2016/425. The CE marking certifies that the conformity assessment process required by the applicable legislation has been completed.

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 PPE varies in color, materials, or components, it is necessary to assess whether such differences could affect its safety performance and compliance with the requirements of the applicable standards.

Based on the characteristics of the variants, the technical tests necessary 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 evaluation of the variants makes it possible to define the certification process in a consistent manner, avoiding unnecessary testing and ensuring a smooth certification process that applies 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 light of the applicable requirements and the reference standard. A non-compliant result does not automatically lead to the termination of the process, but indicates the need to:

Identify the causes of nonconformity (e.g., materials, design, or performance), evaluate possible modifications to the product or its components, and define the additional tests required to demonstrate updated conformity.

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 approach to managing test results ensures a smooth and consistent certification process, in compliance with applicable regulatory requirements.