CE Marking Requirements: A Step-by-Step Route for Exporters

Who must meet CE marking requirements?

CE marking requirements fall on the manufacturer. Under EU law, the manufacturer is the company that makes a product, or has it designed or made, and sells it under its own name or trademark. You do not need to own a factory. If the product carries your brand, you are the manufacturer, wherever you are located.

EU companies can take on the same role. An importer or distributor becomes the manufacturer when it sells a product under its own name or trademark, or when it modifies a product already on the market in a way that may affect compliance.

The CE marking may only be affixed to products covered by EU legislation that provides for it. Machinery, electrical equipment, radio equipment, toys and pressure equipment are examples. Many consumer products, such as furniture or bicycles, fall only under the General Product Safety Regulation (GPSR) and must not bear the CE marking. Putting CE on a product outside the scope is itself an infringement.

Step 1: Identify every EU law that applies

A product can fall under several EU laws at the same time, and it must meet all of them. For each candidate law, read three parts in this order: the subject matter (usually Article 1), the scope and exclusions (usually Article 2, sometimes with an annex) and the definitions. Consider the intended use and reasonably foreseeable misuse.

For industrial products, the core laws are:

• Machinery: Directive 2006/42/EC until 19 January 2027, then Regulation (EU) 2023/1230 from 20 January 2027
• Low Voltage Directive (LVD), Directive 2014/35/EU, for 50 to 1000 V AC or 75 to 1500 V DC
• Electromagnetic Compatibility (EMC) Directive, Directive 2014/30/EU
• Radio Equipment Directive (RED), Directive 2014/53/EU
• ATEX Directive 2014/34/EU, for equipment used in potentially explosive atmospheres
• Pressure Equipment Directive (PED), Directive 2014/68/EU, above 0.5 bar
• RoHS Directive 2011/65/EU, on hazardous substances in electrical and electronic equipment

These laws interact. For machinery, electrical hazards are covered by the machinery law, so there is no separate LVD assessment. For radio equipment, the RED covers safety and EMC, so the LVD and the EMC Directive are not applied separately. RoHS usually applies on top. Record each decision, including the laws you excluded and the article or annex that supports the choice. This record becomes the first page of your technical file. The CE Marking Fundamentals course includes an applicability checklist for this step.

Step 2: Select harmonised standards

EU laws set essential requirements: the results a product must achieve. Harmonised standards describe technical ways to reach them. A European standard (EN) becomes harmonised when it is developed on a request from the European Commission and its reference is published in the Official Journal of the European Union. Applying it then gives a presumption of conformity.

That presumption has limits. It covers only the requirements listed in the standard's Annex ZA or ZZ table (Annex A for ETSI standards), and only for products within its scope. Harmonised standards are voluntary, but without them you must show yourself how each requirement is met. Record the full reference with year and amendments, and check the edition currently cited and any restrictions in the citation. Standards from outside the EU, such as UL or GB standards, give no presumption of conformity in the EU. Our guide to harmonised standards and presumption of conformity explains how to find the right edition.

Step 3: Complete the conformity assessment

Conformity assessment shows that the product meets the essential requirements before it is placed on the market. Decision No 768/2008/EC provides a menu of procedures, called modules, identified by letters from A to H. Each law selects the modules it allows.

Module A, internal production control, means the manufacturer carries out the whole assessment alone. A notified body is a third-party organisation designated by a Member State for specific laws, modules and products. Its scope can be checked in NANDO, the Commission's public database. Even under module A, you need complete evidence, because a market surveillance authority can ask for it. Our guide do I need a notified body goes through the rules law by law.

Step 4: Build the technical file and sign the declaration

The technical documentation is your evidence of conformity. Under module A of Decision No 768/2008/EC it contains, wherever applicable:

• a general description of the product, its intended use and its variants
• design and manufacturing drawings, with the explanations needed to understand them
• the list of standards applied, in full or in part, and the other solutions used
• results of design calculations and examinations, and test reports
• an adequate analysis and assessment of the risks

The file must be ready before the product is placed on the market. You keep it for 10 years after placing on the market, unless the specific law says otherwise, and update it after every design change. Market surveillance authorities can see it on a reasoned request. Customers have no general right to it.

Next, you draw up the EU Declaration of Conformity (DoC). When several laws apply, you sign a single declaration that lists all of them. It must be translated into the language or languages required by the Member State where the product is made available. See our guide to the EU declaration of conformity for its content.

Step 5: Appoint an EU partner and prepare the labels

Article 4 of Regulation (EU) 2019/1020 covers products under a list of EU laws, including machinery, LVD, EMC, RED and RoHS. For these products, an economic operator established in the EU must be responsible for certain compliance tasks. A manufacturer outside the EU cannot fill this role itself. The operator can be an importer, an EU authorised representative or, when none of these is in the EU, a fulfilment service provider.

Only the manufacturer, or its authorised representative acting on its behalf, may affix the CE marking. It comes last, after the conformity assessment, the technical file and the declaration. The marking keeps the official proportions, is at least 5 mm high unless the specific law says otherwise, and must be visible, legible and indelible. A four-digit number after it, shown as CE xxxx, appears only when a notified body is involved in the production control phase.

The product, or where that is not possible its packaging or an accompanying document, also needs:

• the manufacturer's name, registered trade name or trade mark, and postal address
• a type, batch or serial number
• the importer's name and address, when there is an importer
• the name and contact details of the Article 4 operator
• instructions and safety information in a language users in the country of sale can easily understand

Customs may suspend release for free circulation when required documents, markings or Article 4 details are missing. Check that the model name matches on the plate, the declaration, the instructions and the technical file.

Step 6: Keep the product compliant after the sale

Placing on the market happens unit by unit. Each unit must meet the rules in force on the day it is placed on the market, so a design that complied in the past is not automatically compliant today. Investigate complaints, keep a register and take corrective action when a product does not conform. If it presents a risk, inform the national authorities.

Several dates are approaching. The Machinery Regulation applies from 20 January 2027. The Cyber Resilience Act (CRA), Regulation (EU) 2024/2847, has reporting obligations from 11 September 2026 and its main obligations from 11 December 2027. Check the latest position in the Official Journal before you plan.

Key points

• Identify every applicable EU law and record why others do not apply.
• Harmonised standards are voluntary but give a presumption of conformity for the requirements they cover.
• Most products follow module A, without a notified body, but the evidence must still be complete.
• Prepare the technical file and a single EU declaration before the first unit is placed on the market.
• For listed legislation, name an EU-established responsible operator on the product or its documents.