Personal Protective Equipment

PPE CE Marking: Your Expert Partner in 2016/425/EU Compliance

Workplace safety and employee health are the top priority in every industry. The Personal Protective Equipment (PPE) you manufacture must not only protect workers from hazards but also meet the highest standards of legal compliance. The key to free movement and reliability in the European Union is the CE Marking conformity with the 2016/425/EU PPE Regulation.

At ATC International, we offer expert support to ensure your products complete this critical process smoothly and quickly.

Expertise Across a Wide Range of PPE Products

Our services cover a wide spectrum of PPE regardless of the hazard level. We determine and implement the most appropriate path according to your product’s category classification and requirements.

Primary PPE Products We Service:

  • Protective Gloves: Against chemical, cut, impact, and thermal risks.
  • Protective Clothing: Garments for high visibility, heat/flame, chemical, and mechanical risks.
  • Safety Footwear: Including Safety (S), Protective (P), and Occupational (O) footwear.
  • Masks and Respiratory Protection: Such as FFP1, FFP2, FFP3 masks for dust, liquid aerosols, and gases.
  • Fall Arrest Equipment: Safety harnesses, lanyards, energy absorbers, and connectors.
  • Protective Headgear: Industrial helmets, safety glasses, and face shields.

The Core of CE Marking: Module B and Module C2 Services

The CE Marking process for high-risk (Category III) or complex PPE requires supervision by a Notified Body. ATC International provides specialized guidance in the two essential modules most often needed by manufacturers: Module B and Module C2.

1. Module B: EU Type-Examination Certificate

Module B (EU Type-Examination) is the crucial step that proves a representative sample of your PPE production fully complies with the essential health and safety requirements outlined in the 2016/425/EU Regulation.

  • We review the technical design file and ensure the necessary testing meets harmonized standards.
  • Upon successful completion, we facilitate the issuance of the EU Type-Examination Certificate (CE Certificate) for your product. This certificate is the official proof of design conformity.

2. Module C2: Conformity to Type Based on Internal Production Control

Once design conformity is established with Module B, Module C2 comes into play. This module guarantees that all mass-produced PPE units are manufactured consistently and in conformity with the approved type. Our Module C2 service covers:

  • Coordinating the periodic surveillance of your mass production process and final products to ensure ongoing conformity to the approved type.
  • Supporting you in monitoring the necessary procedures to maintain compliance with the regulation.
  • This ensures that every product you place on the market continually meets the requirements specified in your EU Type-Examination Certificate.

Why Choose ATC International?

CE Marking and PPE conformity procedures are complex and detailed. The right consultancy minimizes legal risks and accelerates your time-to-market.

  • Sectoral Expertise: You work with a team proficient in the latest requirements of the 2016/425/EU Regulation and relevant harmonized standards.
  • Modular Solutions: We offer tailored, end-to-end solutions in all conformity assessment modules, including Module B and Module C2.
  • Trust and Access: The CE mark enables you to confidently sell your products not only within the European Union but also in all global markets that recognize this mark.

Contact us today to elevate the reliability and legal compliance of your PPE products. We are ready to be your strongest partner on your CE Marking journey!