Manufacturer Obligations

If you manufacture ATEX equipment, the Equipment Directive (2014/34/EU) places primary responsibility for safety squarely on your shoulders. Article 6 sets out what you must do before, during, and after placing products on the EU market. These aren't suggestions—failure to comply can mean product recalls, significant financial penalties, and serious liability if an incident occurs.

Your Core Obligation

The fundamental requirement is straightforward: ensure your equipment is designed and manufactured to meet the essential health and safety requirements in Annex II of the directive. The EC ATEX Guidelines (§74-77) explain that this means conducting proper risk assessments during the design phase, building in appropriate protection measures, selecting suitable materials, and documenting everything thoroughly. You must demonstrate that your product is safe for its intended use in explosive atmospheres—not just assert it.

Before Placing on the Market

Before a single unit reaches the EU market, several things must be completed:

• Technical documentation: Compile comprehensive documentation demonstrating how the product meets every applicable requirement
• Conformity assessment: Complete the procedures appropriate for your equipment category—EU-Type Examination for Category 1 and 2, potentially Module A (self-certification) for Category 3
• EU Declaration of Conformity: Prepare and sign a formal declaration that your product meets all requirements
• ATEX marking: Affix CE marking and explosion protection marking correctly

Traceability and Information

Every product must be traceable. You must put your name, trade name or trademark, and postal contact address on the product itself. Each unit needs a type, batch, or serial number for identification. Instructions and safety information must accompany the product in a language that end-users in the destination market can understand.

The technical documentation must be retained for ten years after the last product is placed on the market. This documentation is your proof of compliance—if a market surveillance authority questions your product, this is what you produce. Without it, you cannot demonstrate that your product meets requirements.

Ongoing Obligations After Sale

Your responsibilities don't end when the product ships. If you discover—or have reason to believe—that a product you've sold doesn't comply with the directive's requirements, you must act immediately: take corrective action (fix, withdraw, or recall as appropriate), inform the competent authorities in every Member State where the product was sold, and provide full details of the non-conformity and the corrective measures you're taking.

You must cooperate with market surveillance authorities whenever they request documentation or information. This includes making technical files available, answering questions about your products, and taking action if authorities determine your products pose risks. Obstruction or failure to cooperate can result in enforcement action beyond just the product issue.

The Relationship with Other Economic Operators

While importers and distributors also have obligations under the directive, as the manufacturer you bear ultimate responsibility for the product's safety and compliance. If an importer or distributor identifies a compliance issue, the trail leads back to you. This is why getting the design, assessment, and documentation right from the start is so important—it's far cheaper to do it properly upfront than to deal with recalls and liability later.

When You Become a Manufacturer

One important nuance from the EC ATEX Guidelines: if you place a product on the market under your own name or trademark, or modify a product in a way that could affect compliance, you take on manufacturer obligations—even if you didn't physically make the product. This applies to own-brand labelling and to modifications made by distributors or integrators. If you're assembling components into a complete assembly, you're the manufacturer of that assembly.