Module C2 Certification Service (conformity to type based on internal production control plus supervised product checks at random intervals)

The Personal Protective Equipment products falling into category III according to EU 2016/425 regulation shall be monitored by a Notified Body for the homogeneity of the manufacturing of the PPE to the EU Type Examination certification based on either Annex VII (Module C2) or Annex VIII (Module D) of the regulation. The application for Module C2 (Annex VII) will be accepted with the application of the manufacturer. The application for certification shall be annexed with all necessary technical and official documentation by the manufacturer also the valid EU Type Examination Certificate and its technical annexes in case the EU Type Examination Certificate is not issued by Universal Certification.

Universal Certification will review the application and technical documentation provided by the manufacturer and will send a proposal for Module C2 certification with the service fee and monitoring method for homogeneity of the PPE in case Universal Certification have necessary resources for the manufacturer.

Universal Certification Module C2 service for monitoring the product homogeneity will be based on sampling of the product from an agreed location of the product and conduct necessary examinations to verify the samples have identical performance as stated in the EU Type Examination Certificate. In addition to sampling and re-testing of the PPE, Universal Certification will conduct an onsite audit for the effectiveness of the internal quality control processes run by the manufacturer. This audit will focus on the evidences of internal production control activities and records. These activities will be carried out minimum on a yearly basis.

The sampling activity of the PPE and repeating some of the performance tests maybe increased by Universal Certification depending on the quantity of manufactured PPE, complaints received from the market and information from the market surveillance authorities.

Universal Certification will suspend or withdraw the Module C2 contract and certificates upon insufficient cooperation of the manufacturer on Module C2 monitoring activities or insufficient corrective actions taken by the manufacturers.

You can download the application form for Module C2 Certification Application Form here

The technical documentation shall be annexed to the application is explained in the Annex III of the EU 2016/425 regulation. The EU Type Examination Certificate and annexes shall be annexed to the application form if not issued by Universal Certification. For more information please review Annex VII of the EU 2016/425 regulation.

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