Personal protective equipment (PPE) may only be made available on the EU market if it complies with Regulation (EU) 2016/425. For this purpose, special requirements must be met, including successful completion of the EU type-examination (in accordance with PPE Regulation (EU) 2016/425; Module B). But how can you apply for this and what do you have to consider? The following is an overview of the most important information:
The EU type-examination is a conformity assessment procedure, in which a notified body (e.g. OETI; NB 0534) examines, verifies and certifies that the PPE meets the requirements of Regulation (EU) 2016/425 (in short: "PPE Regulation"). This is done by assessing the technical documentation, the test certificates and testing a sample of the complete PPE (type) representative of the planned production.
Application variants: Which one should be used?
In total, there are three different variants:
As engineer Judith Pointner, Head of Technology - Textile Technology and Personal Protective Equipment (PPE) at OETI explains, the following documents are necessary in order to submit an application: "For this, a corresponding application must be submitted, which must include the designation of the personal protective equipment and the standards according to which the PPE is to be certified, furthermore, the required test certificates on the material properties must be submitted as well. To this end, the signed application including the certification agreement must be submitted. It is important to note that no type-examination can commence without a signed contract."
There are special requirements to be met regarding the technical documentation for a type-examination. Thus, the information required in Regulation (EU) 2016/425 must be included. The technical documentation must include a detailed description of the PPE, the standards applied, the label designs, the user information and much more – The layout of the technical documentation is not defined. We provide our customers with a document containing all the required information:
Which manufactured types are needed?
For the EU type-examination, at least one complete version of each PPE must be submitted. The specific amount can vary depending on the type. This depends on the number of design variants. Material testing may also be required for manufactured PPE. This depends on the desired standards. Judith Pointner explains: "The verifications and material tests are also very specific and depend, for example, on the number of materials, material compositions or accessories used. However, it is important to note that they must be prepared by an accredited testing laboratory and must not be older than five years."
The submitted information, technical documentation, samples, test reports and evidence are evaluated by an expert from the certification body. During the type-examination, the verification of compliance with safety-related material requirements (test results) is checked as well as the technical documentation and manufacturing execution. If required verification of material tests is missing, the
corresponding verification (test reports) must be submitted later or tests performed. The applicant can order them from OETI's testing office. After completion, or once an EU type-examination has been carried out, a statement of conformity is completed. Based on this, the applicant issues an EU Declaration of Conformity on their own responsibility.
If you have any questions or need further information, please feel free to contact the team of experts at OETI:
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