STAGE 1. EU - type examination.
Module B - EU type examination certificate.
The manufacturer must draw up the technical documentation containing all the details of the product envisaged for manufacture in accordance with ANNEX III to Regulation (EU) 2016/425. The manufacturer must submit an application for EU-type examination to only one notified body such as CTEC, together with the technical documentation and representative specimens of the intended production. After examining the technical documentation, the Notified Body (CTEC) shall arrange for the necessary tests to be carried out to verify that the product satisfies the relevant essential health and safety requirements. Where the type meets the essential health and safety requirements, the notified body (CТEC) shall issue an EU-type examination certificate to the manufacturer. The certificate is valid for 5 years, during which time the EU-type examination certificate is subject to review if necessary.
STAGE 2. Production control.
Module C2 or Module D conformity to type assessment.
The EU-type examination certificate does not in itself guarantee the right to affix the CE marking to a Category III product. For PPE category III, the homogeneity of production must be demonstrated by CTEC as a notified body in addition to the type examination certificate. The manufacturer can decide which module to choose.
Selecting module C2 Conformity to type based on internal production control plus random inspections of products at random intervals.
The notified body CTEC carries out an inspection by examination and appropriate testing of the products in order to check the homogeneity of manufacture and conformity of the personal protective equipment with the type described in the EU-type examination certificate and with the relevant essential health and safety requirements. The inspections of the products are performed at least once a year, at random intervals, determined by CTEC. The first inspections of the products shall be carried out within one year from the date of issue of the EU-type examination certificate.
Selecting module D Conformity to type based on product quality assurance.
The manufacturer must have developed and implemented an approved quality system for production, inspection and testing of the final product. The notified body CTEC assesses the quality system to verify that it complies with the type as described in the EU-type examination certificate and with the applicable requirements of Regulation (EU) 425/2016. The notified body shall inform the manufacturer of its approval decision after a positive assessment. The notified body must periodically carry out on-the-spot audits at least once a year to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. In addition, the notified body may pay unannounced visits to the manufacturer and may carry out or assign the PPE examinations or tests.
STAGE 3. EU declaration of conformity
The manufacturer must draw up an EU declaration of conformity for each model of personal protective equipment. The EU declaration of conformity (category III) must indicate the notified body CTEC, which carries out EU type examination and controls the production (module C2 or D).
STAGE 4. CE marking
The manufacturer must affix the CE marking to each PPE (category III) and affix the identification number NB1871 to the notified body CTEC.