What does the ATEX regulation say?
Legal background
The main EU instrument for ATEX product compliance is Directive 2014/34/EU. When placing products on the market (or using them for their own purposes), manufacturers must ensure the products are designed and manufactured in line with the essential health and safety requirements (EHSRs) in Annex II.
Obelis supports ATEX compliance strategies and documentation for products intended to be placed on the EU market under Directive 2014/34/EU.
Manufacturers should ensure conformity in:
- Drawing up technical documentation and apply the relevant conformity assessment route
- Issue an EU Declaration of Conformity and affix the CE marking (for products other than component)
- For components to draw up a written attestation of conformity (as applicable)
- Retain technical documentation and the EU DoC for 10 years after placing on the market
- Apply the required explosion protection marking (and related markings where applicable)
Our services
Support for ATEX Compliance in the EU
Obelis provides end-to-end support for ATEX Directive 2014/34/EU compliance, helping manufacturers determine ATEX scope, classify products, and define the required conformity assessment route. We assist in preparing complete technical documentation, evidence files, and compliant CE and explosion-protection marking, including the EU Declaration of Conformity (DoC) or required attestations. As your EU Authorised Representative, we safeguard documentation for 10 years, manage market surveillance requests, and coordinate corrective actions or reporting obligations. With our expert guidance, your ATEX equipment enters and remains on the EU market safely, efficiently, and fully compliant.
FAQ
Frequently Asked Questions
Directive 2014/34/EU is the EU legal framework that harmonises Member State rules for equipment and protective systems intended for use in potentially explosive atmospheres, setting product compliance requirements for placing these products on the EU market.
The Directive covers:
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Certain safety, controlling and regulating devices intended for use outside explosive atmospheres but required for (or contributing to) safe functioning with respect to explosion risks
- Components intended to be incorporated into ATEX equipment and protective systems.
An “explosive atmosphere” is a mixture with air, under atmospheric conditions, of flammable substances (gases, vapours, mists or dusts) in which, after ignition, combustion spreads to the entire unburned mixture.
For products other than components, manufacturers must apply the relevant conformity assessment procedure, prepare technical documentation, and draw up an EU Declaration of Conformity (EU DoC). They must also keep technical documentation and the EU DoC available for 10 years after the product has been placed on the market.
For components, the conformity assessment procedures apply except for affixing the CE marking and drawing up the EU Declaration of Conformity. Instead, the manufacturer issues a written attestation of conformity stating the component’s characteristics and how it must be incorporated into equipment/protective systems to support compliance with the applicable essential health and safety requirements.
Directive 2014/34/EU specifies different conformity assessment procedures depending on the equipment group/category and product type, including routes that involve EU-type examination in conjunction with other modules, and routes based on internal production control. For some equipment, the procedure includes internal production control plus communication of technical documentation to a notified body, which acknowledges receipt and retains it.
A manufacturer may appoint an authorised representative through a written mandate.
At minimum, the mandate must allow the authorised representative to:
- Keep the EU DoC/attestation and technical documentation available to market surveillance authorities for 10 years,
- Provide information/documentation to competent authorities upon request, and
- Cooperate with authorities on actions to eliminate risks posed by products within the mandate.
