Regulation (EU) 2016/425 lays down the requirements for the design and manufacture of personal protective equipment (PPE) intended to be made available on the market in order to ensure the protection of the health and safety of users, as well as rules for the free movement of PPE in the European Union. Personal protective equipment shall be classified according to the risk categories set out in Annex I to Regulation (EU) 2016/425.

Products that fall within the scope of the Regulation and are classified as category II or category III must undergo mandatory conformity assessment procedures carried out by an independent third party - a notified body such as CTEC Ltd. PPE intended for production must be assessed by such a body and meet the essential health and safety requirements in order to be placed on the market.


  • What does the CTEC service include?

    The Regulation defines three categories - I, II and III depending on the risks against which PPE is intended to protect users. The conformity assessment modules applicable to the products shall be selected in accordance with these categories. For products falling into category I, the manufacturer is responsible for carrying out internal production control, issuing a declaration of conformity and affixing the "CE" marking. For products of category II, CTEC Ltd., as a notified body, performs EU-type examination (module B).


    Category III products have the highest level of protection, which includes only the risks that can cause very serious consequences, such as death or irreversible damage to the health of the user. For these products, CTEC Ltd., as a notified body, performs EU type examination (module B), and one of the following procedures depending on the choice of the manufacturer:


    • conformity to type based on internal production control with supervision of product inspection at random intervals (module C2) or
    • conformity to type based on production quality assurance (module D) Regulation (EU) 2016/425 on PPE sets out general requirements applicable to all PPE and additional requirements depending on the type of PPE and requirements applicable to specific risks.
  • Mandatory stages before PPE, category III are placed on the market

    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.


  • Basic documents and information

  • Benefits for you

    In a regulated area, testing and product certification are obligatory activities and help to avoid damages, financial risk and image impairment. The certification is a prerequisite for product marketing and is a competitive advantage for the manufacturer. The particular benefits of the certification are:


    • Make sure the manufacturer complies with the applicable regulatory requirements

    • Guarantee to the customer that the product is safe and reliable

    • Increased competitiveness compared to other products

    • Opportunity to conquer new markets

  • Why choose CTEC?

    On 25 March 2021, the notification of CTEC according to Regulation (EU) 2016/425 was announced in the information system of the European Commission NANDO. Thus, following a responsible assessment procedure, we expand our portfolio of services by adding another notification to the other four notifications and becoming the first notified body in Bulgaria to assess the conformity of personal protective equipment.


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Phone.:   +359 (42) 620368

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CTEC number in the information system of the European Commission NANDO (New Approach Notified and Designated Organisations) is NB 1871.