Notified Body 1024 procedures

The practical procedure for assessing the conformity of personal protective equipment in NB 1024 is fully compatible with that applied in other EU countries.

The procedure recommends contacting specialised professionals (see contacts) for in-time consultation on the requirements for conducting assessment activities and prescribed tests, as well as other issues that the customer considers should be discussed.

PPE testing and certification procedure

  1. The manufacturer requests the performance of a partial test (prior consultation with a representative of the relevant laboratory is advisable – see contacts). An Order for testing is submitted, which allows for the specification of the details of the order.
  2. The customer is required to submit an Application for an EU type examination for the testing and assessment of PPE (certification). The application is required to specify the product category, protective properties, conformity assessment method, etc. The customer must also provide the technical documentation on the product to the required extent (see the Application, p. 2). It must be indicated whether the applicant is a manufacturer or a representative of the manufacturer, whether the applicant requires the respective documentation in the electronic form (the certificate is in all cases provided in the printed form version), and whether the certificate should also be issued in English.
  3. RILSA-NB 1024 subsequently prepares a draft contract for the testing of the respective personal protective equipment, which includes the scope of the testing procedure, information on subcontractors, deadlines, the price and the manufacturer’s commitment to use the certificate in practice. The draft contract is then sent to the customer. The customer is given the opportunity to comment on the contract and, following agreement with RILSA-NB 1024, the contract may be supplemented with other information. The two parties subsequently append their signatures to the contract.
  4. The customer is required to deliver samples for testing in the agreed range and amount and to complete the documentation in accordance with the instructions provided by RILSA-NB 1024. Once the terms have been agreed, the customer is required to pay in advance for the testing of the product.
  5. RILSA-NB 1024 performs the tests and compiles the test report. The documentation and the test results are subsequently assessed and the results set out in the Final Certification Report. The results of the assessment are communicated to the customer, whereupon they are required to remit the costs of the certification process.
  6. Following the payment of the costs, RILSA-NB 1024 provides the customer with the test report, the final certification report and, provided that the product meets the requirements of Regulation (EU) 2016/425, an EU type-examination certificate, which is valid in all EU countries.
  7. Based on the technical documentation of the product, the test report, the final certification report and the EU type-examination certificate, the manufacturer (authorised representative) compiles an EU declaration of conformity. The CE marking must be affixed to each PPE. With respect to category III PPE, the CE marking must also be accompanied by the number of the notified body that conducted the inspection.
  8. Concerning category III PPE, the manufacturer (authorised representative) is required to request that the respective notified body conduct inspections at regular annual intervals according to either module C2 or module D. The manufacturer is required to include the reports compiled on such inspections in their documentation, which serves as the basis for the declaration of conformity. Failure to comply with the requirement for annual inspections for category III PPE represents a serious breach of the manufacturer’s obligations! The manufacturer is forbidden from supplying its products to the market without the conducting of such inspections.
  9. In the event that the manufacturer introduces modifications to an approved type of PPE, the parameters are changed or the certification expires (at the earliest 12 and at the latest 6 months prior to the end of validity), the manufacturer is required to request a renewal of the EU type-examination certificate.
  10. The customer is permitted to appeal against the results of tests/certification within 15 days of the issuance of the certification, its suspension or withdrawal, or the preparation of the test report/preparation of the relevant report. Appeals must be submitted in writing stating the reasons for the appeal to the respective notified body. Appeals, complaints and disputes are required to be addressed by the head of the notified body within 30 days.