The CE marking process

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

The CE marking process is the sequence of acts a manufacturer must complete before placing a product on the EU market: identify the applicable harmonisation legislation, determine the conformity assessment route, perform the risk assessment and tests, compile the technical documentation, draw up the EU Declaration of Conformity, and affix the mark. The structure is not invented by the manufacturer — it is set by Decision No 768/2008/EC and the modular conformity assessment procedures of Annex II of that Decision, which each sectoral directive and regulation incorporates by reference.

This page describes the process in six steps that map directly to the obligations of the manufacturer in the reference provisions of Decision 768/2008/EC (Annex I, Article R2). Each step produces specific documentary outputs that must be retained for ten years after the last unit is placed on the market (or longer where a sectoral act so provides — for example, fifteen years for implantable medical devices under Article 10(8) of Regulation (EU) 2017/745).

Legal basis for the process

The procedural structure derives from:

• Decision No 768/2008/EC, Annex I (reference provisions for sectoral legislation) and Annex II (conformity assessment modules).
• Regulation (EC) No 765/2008, Articles 30–32 (general principles of CE marking).
• The sectoral act itself, which selects the applicable modules in its Annex on conformity assessment procedures.
• The Blue Guide 2022 (Commission Notice C/2022/3637), Section 5.

Step 1 — Identify all applicable EU acts

The first task is scoping: which EU harmonisation acts, if any, apply to the product. The page does my product need CE marking? sets out the four-question scope test. A product is almost always covered by more than one act — a mains-powered piece of equipment is typically covered by the Low Voltage Directive, the EMC Directive, RoHS, and one or more category-specific acts (for example, the Machinery Regulation, the Toy Safety Regulation, the Radio Equipment Directive).

Output of this step: a written scope assessment listing every act considered, the relevant article references, the conclusion (in or out of scope), and the rationale. The assessment forms part of the technical file.

Watch for transitional regimes

Three acts are in transition in 2026 and require explicit attention to the date a product is placed on the market:

• Machinery Regulation 2023/1230 applies from 20 January 2027. Until then, Directive 2006/42/EC applies. A product placed on the market on 19 January 2027 falls under the Directive; one placed on 20 January 2027 falls under the Regulation.
• Construction Products Regulation 2024/3110 began to apply on 8 January 2026 for most products, with phased extension over a 15-year transition for specific product families.
• Toy Safety Regulation 2025/2509 entered force on 1 January 2026, with a transitional period during which Directive 2009/48/EC remains applicable for placing on the market.

Step 2 — Identify essential requirements and harmonised standards

Each act in scope sets out essential requirements in an Annex (typically Annex I). These are performance- or outcome-based: a product must be designed and constructed so as to be safe, to be electromagnetically compatible, to meet specific accuracy thresholds, and so on. The act does not prescribe a specific technical solution.

The manufacturer may demonstrate conformity with essential requirements by applying harmonised standards whose references have been published in the Official Journal of the European Union under Article 10(6) of Regulation (EU) No 1025/2012. Use of harmonised standards is voluntary; alternative technical solutions are permitted, provided the manufacturer can demonstrate that the essential requirements are met.

Output: a list of essential requirements applicable to the product, a list of harmonised standards applied (with dated edition), and a note of any requirements addressed by alternative means.

Step 3 — Perform risk assessment and select the conformity assessment procedure

Step 3 has two parallel components.

Risk assessment

Most acts explicitly require a documented risk assessment. The Machinery Regulation 2023/1230 (Annex III, Part 1, point 1) is the most detailed: identify hazards, estimate and evaluate risks, eliminate or reduce risks by design, then by safeguarding, then by user information. The Low Voltage Directive 2014/35/EU (Annex I) and the Toy Safety Regulation 2025/2509 (Article 6) impose comparable obligations. Even where an act does not name "risk assessment", an equivalent analysis is required to justify selection of harmonised standards and conformity solutions.

Conformity assessment procedure

Each act selects one or more conformity assessment modules from those in Annex II of Decision 768/2008/EC. The choice depends on product risk class:

• Module A — Internal production control. The manufacturer assesses its own product, draws up the technical documentation, and declares conformity. No Notified Body. Used for the lowest-risk categories: most products under the EMC Directive, low-risk machinery outside Annex I of the Machinery Regulation, products under the Low Voltage Directive.
• Module B + C, D, E, F, or H. Module B is an EU type-examination by a Notified Body; modules C/D/E/F/H cover production-phase conformity. Required for higher-risk categories: most Annex I (formerly Annex IV) machinery, Class IIa, IIb, and III medical devices, Category III PPE.
• Module G — Unit verification. Each individual product is examined by a Notified Body. Used for one-off equipment such as large pressure vessels.

When a Notified Body's intervention is required, its four-digit identification number must appear next to the CE mark on the finished product (Regulation 765/2008, Article 30(4); Decision 768/2008/EC, Annex II, Module-specific provisions). Notified Bodies are listed in the Commission's NANDO database.

Step 4 — Compile the technical documentation

The technical documentation (often called the technical file) must allow the conformity of the product with the applicable requirements to be assessed. The general contents are specified in Annex II of Decision 768/2008/EC, Module A, point 2, and elaborated in each sectoral act. Typical contents:

• General description of the product
• Conceptual design and manufacturing drawings, schemes of components, sub-assemblies, circuits
• Descriptions and explanations necessary to understand the drawings
• List of harmonised standards applied in full or in part, references published in the OJEU
• Where harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements
• Results of design calculations, examinations carried out, test reports
• The risk assessment
• The EU Declaration of Conformity

Sectoral acts add specific items. The Machinery Regulation requires assembly instructions in the technical file for partly completed machinery (Annex IV, Part B). The Medical Devices Regulation 2017/745 requires post-market surveillance plans and clinical evaluation reports (Annex II and Annex III). See technical documentation for the full inventory.

The documentation must be retained for ten years from the date the last unit was placed on the market, unless the act provides otherwise. It must be made available to a competent authority on reasoned request within a period set by the act — typically "without undue delay".

Step 5 — Draw up the EU Declaration of Conformity

The EU Declaration of Conformity is the manufacturer's signed legal statement that the product conforms to all applicable harmonisation legislation. Annex III of Decision 768/2008/EC sets the model contents; each sectoral act adds act-specific items. A single declaration covers all applicable acts, listing each in turn.

Minimum contents under Annex III:

1. Unique identifier (number) of the declaration
2. Name and address of the manufacturer or authorised representative
3. "This declaration of conformity is issued under the sole responsibility of the manufacturer"
4. Object of the declaration — identification allowing traceability (model, batch or serial number, type designation)
5. List of relevant Union harmonisation legislation
6. References to the relevant harmonised standards used, or to the other technical specifications in relation to which conformity is declared
7. Where applicable, identification of the Notified Body and its certificate number
8. Additional information as required by the relevant act
9. Place and date of issue, signature, name and function of the signatory

The declaration must accompany the product (in practice, usually included in the documentation pack and made available in the language(s) required by each Member State where the product is placed on the market). Sectoral acts may allow electronic availability where this is provided for.

Step 6 — Affix the CE mark and prepare for post-market obligations

The CE mark is then affixed visibly, legibly, and indelibly to the product, or — where the product's nature does not allow — to its packaging and accompanying documents (Regulation 765/2008, Article 30(4)). The Notified Body identification number, where required, is placed next to the mark. The mark is at least 5 mm in height, with the proportions in Annex II of Regulation 765/2008, unless the relevant act provides for a different minimum.

Placing on the market triggers a set of continuing obligations:

• Sample testing, complaint registers, and corrective action — where required by the sectoral act (e.g., Article 7(2) of the Toy Safety Regulation; Article 10(2) of Directive 2014/35/EU)
• Cooperation with market surveillance authorities (Regulation (EU) 2019/1020, Articles 4 and 7) — including responding to information requests and bringing non-compliant products into conformity
• Maintaining the contact information on the product or its packaging
• For products covered by the General Product Safety Regulation 2023/988, additional traceability and incident-notification obligations
• For products covered by an EU database (e.g., EUDAMED for medical devices, the future Digital Product Passport), registration and data-keeping

Document outputs across the six steps

How long the process takes

Timelines depend on the conformity assessment route. As a working order of magnitude:

• Module A (self-declaration) for a low-complexity product: 4–12 weeks, dominated by testing scheduling and document preparation.
• Module B + C for typical Annex I machinery or Category III PPE: 4–9 months, dominated by Notified Body queue times and type-test cycles.
• Class III medical device under MDR (Annex IX–X procedures): commonly 12–24 months, dominated by Notified Body capacity and clinical evaluation review.

Costs vary by sector. The costs and timelines page sets out indicative ranges by directive.

Common errors

• Treating the process as sequential when it is iterative. Risk assessment results often change the choice of harmonised standards, and standards selection sometimes reveals scope items missed at step 1. The first complete pass through steps 1–5 is rarely the final one.
• Completing testing before identifying all applicable acts. Testing to LVD and EMC standards without realising the product is also in scope of the Radio Equipment Directive (which absorbs both) wastes the report; RED requires test reports to specific RED-listed standards.
• Drawing up the Declaration of Conformity before the technical file is complete. The DoC declares that the technical file exists and supports conformity. Signing it before that exists is a documentary infringement irrespective of whether the product is physically compliant.
• Affixing the mark and the Notified Body number where no Notified Body has been engaged. The number is applied only where a Notified Body has been involved in production-phase control; it must reflect a real certificate.
• Not repeating the process after substantial modification. A change in software function, materials, or intended use of a product already on the market triggers a fresh placing-on-market and a fresh conformity assessment.

Sources

• Decision No 768/2008/EC — EUR-Lex.
• Regulation (EC) No 765/2008 — EUR-Lex consolidated text.
• Regulation (EU) 2019/1020 on market surveillance — EUR-Lex.
• Commission Notice — The "Blue Guide" 2022, sections 4–5 — EUR-Lex.
• European Commission — CE marking guidance for manufacturers.