Who Is Required to Have CE Certification?

"Does our product need CE?" is perhaps the single most common question we get at SAFETEST. Unfortunately the answer is too layered for a single sentence, because the CE obligation depends on the product's type, function, energy source and target market. In this article we look at which product groups fall under CE legislation, examples of products that don't, and why CE responsibility isn't limited to the manufacturer alone — different actors across the supply chain also carry obligations.

Who Does the CE Obligation Apply To, and For Which Products?

CE marking is not mandatory "for every product" — only for product groups whose scope the EU has defined through specific directives and regulations. This scope is determined less by what the product does and more by which essential risks it carries (electrical, mechanical, electromagnetic, chemical, etc.). The most reliable way to determine whether a product falls under CE scope is to compare its functional characteristics against the scope provisions of the relevant directives; see our systematic guide, Which Directives Apply to My Product?

The Main Product Groups That Fall Under CE

In practice, the range of product groups falling under CE legislation is quite broad. The most common categories are: all kinds of mechanical machinery and equipment (production lines, machine tools, lifting equipment, agricultural machinery); electrical household appliances and electronic devices; devices with wireless communication capability (Wi-Fi, Bluetooth, GSM-enabled products); toys; personal protective equipment (occupational safety equipment, protective clothing); pressure equipment (boilers, pressure vessels); lifts; gas-burning appliances; medical devices; and equipment used in explosive atmospheres (ATEX scope). Each of these categories is regulated under its own specific directive or regulation and has its own risk-assessment logic.

Especially for companies operating in the machinery manufacturing sector, the core basis for the CE obligation is the Machinery Directive 2006/42/EC (and Regulation (EU) 2023/1230 on machinery, which will progressively take its place). This directive's scope is not limited to the everyday meaning of the word "machine" — any assembly of linked parts, at least one of which moves, designed to perform a specific function, can fall under this definition. See our article What Is the Machinery Regulation? for detail on the scope of machinery safety legislation.

Products Outside CE Scope

CE legislation does not cover every product. Many product groups — food products, cosmetics, pharmaceuticals, non-electrical furniture, textile products (except for certain flammability requirements) — are outside the scope of CE marking and are instead subject to their own dedicated regulatory regimes (food safety legislation, the Cosmetics Regulation, chemical legislation such as REACH). Affixing the CE marking to these product groups is considered misleading, since it is an out-of-scope application, and is contrary to the legislation. This is why a "let's just put CE on everything, it can't hurt" approach is wrong — the marking should only be affixed to products that genuinely fall within scope.

Is Only the Manufacturer Responsible?

One of the most commonly misunderstood aspects of CE legislation is the assumption that responsibility is limited to the manufacturer. In reality, EU legislation places varying levels of responsibility on every actor in the supply chain:

• Manufacturer: Carries the primary and most comprehensive responsibility — from the product's design and preparing the technical file, to signing the declaration of conformity and affixing the CE marking.
• Authorized representative: A person or body within the EU to whom a manufacturer established outside the EU delegates certain tasks (such as holding documentation and communicating with authorities).
• Importer: The party bringing a product from outside the EU onto the EU market for the first time; obligated to verify that the product carries the CE marking and that the technical file and declaration of conformity exist, and to put their own contact details on the product.
• Distributor: The party who places the product on the market in the supply chain but is neither the manufacturer nor the importer; obligated to check with reasonable care whether the product carries the required markings.
• Own-brand labeller: A company selling another manufacturer's product under its own brand is treated as the "manufacturer" under the legislation and assumes all of the manufacturer's responsibilities.

This distinction is especially critical for companies engaged in e-commerce and bulk importing. Simply saying "we're not the manufacturer, we import" does not exempt a company from responsibility — certain verification and record-keeping obligations still apply as an importer. See our article What Is CE Certification? for a detailed breakdown of the manufacturer's legal obligations.

Scale, Export Status and Second-Hand Products

Some manufacturers assume they are exempt from the CE obligation because they operate at small scale or sell only domestically — this is a false assumption. Production scale (including small-workshop-type manufacturing) does not remove the CE obligation. Similarly, because Turkey has aligned most of CE legislation with its own technical regulations under the Customs Union with the EU, CE marking is in practice a requirement even for in-scope products intended only for the Turkish domestic market.

The situation is slightly different for second-hand products: the CE obligation relates mainly to the moment the product was first placed on the market. Reselling a product that was previously legally placed on the EU market generally does not trigger a new CE assessment. However, if a significant structural change, refurbishment, or modification for a different use has been made to the product, this can subject it to a new CE assessment.

Sector Examples: Which Businesses Are Most Often Affected?

Making the business profiles that most often encounter the CE obligation concrete helps make the topic clearer. Companies operating in the metal and machinery manufacturing industry (businesses doing machining, welding, building assembly lines) fall under the Machinery Directive almost without exception. Electronics companies making household electrical appliances, lighting fixtures or power supplies fall under the Low Voltage Directive. Technology start-ups developing smart home devices, IoT sensors, or products with a wireless communication module fall under the Radio Equipment Directive, and often overlook this scope — because a company positioning itself as a "software company" can cause the CE obligation of the hardware component to be overlooked. Companies manufacturing or distributing occupational safety equipment (hard hats, safety harnesses, protective clothing) are subject to personal protective equipment legislation. Finally, importer companies bringing bulk products from China, the Far East or other third countries and selling them in the Turkish and EU markets face direct verification and record-keeping obligations even though they are not the manufacturer — such companies often expose themselves to risk by assuming CE responsibility belongs solely to the overseas supplier.

This sectoral diversity shows why CE consultancy cannot start from a single template — it needs to begin with an analysis specific to each company's product portfolio. Even two companies in the same sector can be subject to entirely different combinations of directives depending on the technical characteristics of their products (power source, presence of a wireless module, risk class).

Relevant Directives and Standards

The core legislation to consult when determining CE scope depends on the type of product. The main reference points are: Directive 2006/42/EC on machinery for machinery and mechanical equipment (progressively replaced by Regulation (EU) 2023/1230 on machinery from 20 January 2027); the Low Voltage Directive 2014/35/EU for electrical equipment; the Radio Equipment Directive 2014/53/EU for wireless devices; and the RoHS Directive 2011/65/EU for restrictions on hazardous substances in electronic products. Regulation (EC) No 765/2008 and Decision No 768/2008/EC, which form the common framework for these directives, set out the general principles of CE marking and the conformity assessment modules.

Step by Step

1. Clearly define your product's function, energy source and intended use.
2. Determine which EU directives and regulations' scope provisions your product falls under.
3. Clarify your company's role in the supply chain (manufacturer, importer, distributor, own-brand seller).
4. List the legal obligations (documentation, verification, record-keeping) that come with your role.
5. If in scope, start the risk analysis and technical file process.
6. Determine whether self-declaration is sufficient or notified body involvement is required.
7. Put written agreements in place with other parties in your supply chain (supplier, importer) that clarify the division of responsibility.
8. Carry out one final conformity check before completing CE marking and placing the product on the market.

Most Common Mistakes

• Operating on a wrong assumption such as "we're a small-scale manufacturer, CE doesn't apply to us."
• Assuming CE isn't required simply because sales are domestic only.
• Assuming an importer or distributor role is fully exempt from manufacturer responsibility.
• Unnecessarily affixing the CE marking to an out-of-scope product (for example, a textile product not subject to CE legislation).
• Not realizing that manufacturer obligations have been assumed for a product placed on the market under one's own brand.
• Overlooking that a significant modification made to a product can require a new CE assessment.
• Failing to notice that a product falls under more than one directive at once and assessing it against only a single piece of legislation.

Frequently Asked Questions

How Scope Determination Feeds Into Internal Company Processes

Correctly determining CE scope isn't just a matter for the legal or engineering department — it needs to become a shared responsibility across purchasing, R&D, quality and sales teams. For example, the purchasing team should ask, when buying a component from a new supplier, whether that component falls under CE scope and whether the supplier has the documentation capacity to prove it. The R&D team should be aware, when adding a new product feature (such as wireless connectivity), that this can expand the product's directive scope. The sales team should assess, when entering a new market, that market's position with respect to CE legislation (an EU member, an EEA member, or a Customs Union country such as Turkey). This cross-functional awareness ensures that CE scope is managed correctly not just at the start of a project, but throughout the product's entire lifecycle.

Conclusion

The CE obligation is not a single-criterion question — it is a multidimensional matter that needs to be assessed together based on the product's type, its functional risks and your company's role in the supply chain. Determining scope incorrectly can lead to both unnecessary costs and serious legal risk. This is why clearly establishing, at the very start of the process, where your product and your company stand with respect to CE legislation is critical to the whole process running smoothly.