The CE marking process

Last reviewed: October 2026 · Sources listed at the end of this page.

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, Article 30 (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 — mains-powered household electrical equipment, for example, is typically covered by the Low Voltage Directive, the EMC Directive and RoHS, and adding a radio module brings in the Radio Equipment Directive in place of the first two.

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 has applied since 8 January 2026, but key parts of Regulation 305/2011 stay in force until 8 January 2040 (Article 94), so existing product families continue under the old rules until they are moved across.
• Toy Safety Regulation 2025/2509 entered into force on 1 January 2026 and generally applies from 1 August 2030; until then 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. For machinery, check the status of citations under the Regulation: citations under the Directive do not carry over.

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 B, 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. Modules built on the Decision 768/2008/EC model require "an adequate analysis and assessment of the risk(s)" in the technical documentation (for example Directive 2014/35/EU, Annex III, point 2), and the Toy Safety Directive 2009/48/EC (Article 18) and, from 2030, Regulation 2025/2509 (Article 25) require a safety assessment. 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 lower-risk categories: most products under the EMC Directive, all products under the Low Voltage Directive, and machinery outside Annex I of the Machinery Regulation.
• Module B + C, C2, D, E, or F, or Module H. Module B is EU type-examination by a Notified Body; the module that follows covers production. Module H is full quality assurance. Examples: Annex I, Part A machinery (B + C, H, or G) and Category II and III PPE. Medical devices above the lowest class follow the MDR's own procedures in Annexes IX to XI, which use similar logic.
• Module G — Unit verification. Each individual product is examined by a Notified Body. Used for one-off equipment such as large pressure vessels.

Where a Notified Body is involved in the production control phase, its four-digit identification number follows the CE mark (Decision 768/2008/EC, Annex I, Article R12(3)); sectoral acts can vary this, for example Article 24(3) of the Machinery Regulation. 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
• A copy of the EU Declaration of Conformity, where the act lists it (for example Directive 2014/53/EU, Annex V)

Sectoral acts add specific items. The Machinery Regulation sets a separate technical documentation list for partly completed machinery (Annex IV, Part B), which must come with assembly instructions (Annex XI). 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 provided to a competent national authority on reasoned request (Decision 768/2008/EC, Annex I, Article R2(9)).

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, and sectoral acts repeat or adapt them. Where several acts apply, a single declaration covers them all (Decision 768/2008/EC, Article 5).

Minimum contents under Annex III:

1. A number identifying the product (it may refer to a product, batch, type or serial number)
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

Some acts, including those on machinery, radio equipment, ATEX equipment, measuring instruments, recreational craft and lifts, require the declaration to accompany the product (Blue Guide 2022, section 4.4), and some allow a simplified version or a web link instead. Under others, such as the LVD and the EMC Directive, it is kept with the technical documentation and provided to authorities on request.

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 its data plate, or, where the product's nature does not allow, to its packaging and any accompanying documents the act provides for (Decision 768/2008/EC, Annex I, Article R12(1)). The Notified Body identification number, where required, follows 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 6(4) of Directive 2014/35/EU; Article 7(4) of Regulation 2025/2509, once it applies)
• 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

There is no statutory timetable. Duration depends mainly on the route:

• Module A: set by test scheduling, document preparation and how quickly design issues are fixed.
• Routes with a Notified Body: add the body's availability, type-test cycles or quality-system audits. Ask for a timetable with each quotation.
• Higher-class medical devices: usually the longest route, because of clinical evaluation review and Notified Body capacity.

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 radio equipment leaves gaps: the Radio Equipment Directive absorbs those requirements (Article 3(1)) but adds its own, such as effective use of radio spectrum (Article 3(2)).
• Drawing up the Declaration of Conformity before the technical file is complete. The DoC is drawn up once compliance has been demonstrated (Decision 768/2008/EC, Annex I, Article R2(2)). Signing it before the evidence exists makes an unsupported legal statement, even if the product turns out to be compliant.
• Affixing the mark and the Notified Body number where no Notified Body has been engaged. The number must reflect a body's actual involvement, normally in production-phase control.
• Not repeating the process after substantial modification. A change in software function, materials, or intended use of a product already on the market can make it a new product, needing a fresh conformity assessment.

Frequently asked questions

Can I do CE marking myself?

Yes, where the act allows Module A (internal production control). You then run the assessment, compile the file, sign the declaration and affix the mark yourself. If the act requires a Notified Body, that part must be done by a body notified for your act and product; find one in NANDO.

Does anyone approve the CE mark before I use it?

No authority approves it. Even where a Notified Body issues a certificate, the manufacturer affixes the mark and carries the responsibility.

Who does the process if the manufacturer is outside the EU?

The manufacturer remains responsible. It may mandate an authorised representative for some tasks, but drawing up the technical documentation cannot be delegated that way. For most CE products an economic operator established in the EU is also required (Regulation (EU) 2019/1020, Article 4).

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.