The most practical question that comes up when preparing a product for the European market is: how do you actually obtain CE certification, where does the process start, and who needs to do what? In our previous article we covered what CE certification is conceptually; in this article we walk through the process end to end as a practical roadmap, from product analysis to CE marking. Our goal is to lay out the concrete steps a machine manufacturer, an importer or a quality manager needs in order to plan the process from start to finish.
How Does the CE Certification Process Work, Start to Finish?
The process of obtaining CE certification doesn't begin with a single application form and end with an "approval" — it is an engineering process made up of interconnected technical stages. For the process to run smoothly, each stage needs to be carried out in the right order with the right inputs. Below, we walk through these stages together with the questions that come up most often in practice.
1. Product and Scope Analysis
The first step in the process is clarifying the technical definition of the product: its function, working principle, energy source (electrical, hydraulic, pneumatic), operating environment and target user group are all determined. This information becomes the fundamental input for determining which EU directives and regulations apply to the product. A mistake made at this stage, if only discovered much later in the process, leads to serious time and cost losses — which is why scope analysis is a stage that should never be rushed. See our article Which Directives Apply to My Product? for help determining which legislation applies to your product.
2. Selecting the Directive and Harmonized Standards
Once the scope is clear, the harmonized (EN) standards to be used to meet the essential requirements of the relevant directives are determined. Standard selection has a direct effect on product design; for example, the dimensions of a machine's protective guards, the IP protection rating of an electrical panel, or the electromagnetic emission limits of a device are all described by the standards selected. See our article What Is a Harmonized Standard? for more on how harmonized standards work and how to track current lists.
3. Risk Analysis and Design Review
Especially for products under the Machinery Directive, risk analysis forms the backbone of the process. At this stage, all hazards the product may present throughout its lifecycle (installation, normal use, maintenance, malfunction, and even reasonably foreseeable misuse) are systematically listed, a risk level is assessed for each hazard, and mitigation measures (design elimination, protective devices, warning labels, user information) are determined. Risk analysis results very often require design changes, which is why it is recommended to start the process as early as possible — ideally at the design stage. See our article How Is Risk Analysis Done? for the detailed method.
4. Building the Technical File
Once the risk analysis and standard selection are clear, work begins on the technical file, which brings together all the technical evidence: general design drawings, circuit diagrams, material lists, calculations, the list of applied standards, the risk assessment report and test results are all part of this file. The technical file is the "evidence file" of the CE process — it is the first document that will be requested during an audit. See our guide How to Prepare a Technical File? for detailed information on its content and preparation.
5. Planning and Carrying Out Laboratory Tests
Depending on the product type, tests such as electrical safety (LVD), radio performance (RED), mechanical strength, noise emission or IP/IK protection rating may be required. See our article When Are Tests Required in the CE Process? for guidance on when and under what conditions tests are required. If test planning is not done early, laboratory appointment lead times can significantly extend the overall project timeline — which is why it is recommended to plan tests as soon as the design is finalized.
6. Self-Declaration or Notified Body Involvement?
Based on the test results and risk analysis, it is determined whether the product can proceed through self-declaration or requires the involvement of an independent notified body. This decision directly affects the total duration and cost of the process; processes requiring notified body involvement must account for additional application, review and certification time. See our article What Is a Notified Body? for more detail.
7. The User Manual and Labeling
In parallel with the technical file, a user manual is prepared covering the safe installation, use, maintenance and fault conditions of the product. The manual's content must also align with legal requirements; an incomplete or overly generic manual can be flagged as a non-conformity during an audit. See our guide User Manual Preparation Guide for details, and How to Prepare the CE Label? to learn the technical rules for the CE marking.
8. Signing the Declaration of Conformity and CE Marking
Once all technical evidence is complete, the EU Declaration of Conformity is prepared and signed by an authorized person. The CE marking is then affixed to the product, its label or packaging in accordance with the correct size and proportion rules. From this point on, the product is ready to be placed on the EU market.
Relevant Directives and Standards
Which directives shape the process depends on the nature of the product. The most commonly applied pieces of legislation are: Directive 2006/42/EC on machinery for mechanical equipment (to be progressively transferred to Regulation (EU) 2023/1230 on machinery by 2027), the Low Voltage Directive 2014/35/EU for electrical products, the Radio Equipment Directive 2014/53/EU for devices with wireless communication capability, and the RoHS Directive 2011/65/EU for restrictions on hazardous substances in electronic products. The administrative framework of the process is set out by the New Legislative Framework, consisting of Regulation (EC) No 765/2008 and Decision No 768/2008/EC.
| Stage | Responsible Party | Typical Output |
|---|---|---|
| Product and scope analysis | Manufacturer / R&D / Consultant | List of applicable directives and standards |
| Risk analysis | Engineering team / Consultant | Risk assessment report |
| Laboratory testing | Accredited test laboratory | Test reports |
| Technical file | Manufacturer / Consultant | Technical file package |
| Notified body review (if required) | Notified body | EU-type examination certificate |
| Declaration of conformity and marking | Manufacturer | EU Declaration of Conformity + CE marking |
Step by Step
- Clarify the technical definition of your product and your target market.
- Determine the applicable EU directives and regulations.
- Identify the relevant harmonized standards and compare them against the design.
- Carry out the risk analysis and implement any required design revisions.
- Book and complete laboratory tests.
- Build the technical file with all evidence (drawings, calculations, test reports, risk analysis).
- Determine whether self-declaration or notified body involvement is required, and apply if needed.
- Prepare the user manual and the product label.
- Sign the EU Declaration of Conformity and affix the CE marking to the product.
- Keep the technical file for the period required by law and update it whenever the design changes.
Most Common Mistakes
- Getting involved in the process only at the "final stage," after the design is already complete.
- Choosing directives and standards superficially, forcing revisions later in the process.
- Booking laboratory test appointments late, extending the overall project timeline.
- Treating the risk analysis as a box-ticking formality rather than a genuine assessment.
- Preparing the user manual as a generic template and skipping product-specific hazards.
- Only realizing the notified body requirement at the end of the process.
- Keeping the technical file as scattered documents that cannot be quickly presented during an audit.
- Signing the declaration of conformity using a template with incomplete or outdated content.
Frequently Asked Questions
What is the first thing to do to obtain CE certification?
The first step is to clarify the product's technical characteristics and determine which EU directives and regulations it falls under. Getting this wrong can require serious revisions later in the process.
Which documents need to be prepared to obtain CE certification?
At a minimum, a risk analysis, a technical file, a user manual and an EU Declaration of Conformity must be prepared. Depending on the product's risk class, laboratory test reports and a notified body certificate may also be required.
Is laboratory testing always required for CE certification?
There is no absolute requirement for laboratory testing on every product; for some low-risk products, conformity can be demonstrated through analysis and calculation. However, for electrical/electronic products falling under LVD or RED, testing is usually unavoidable.
Is consultancy required to obtain CE certification?
It is not legally required — a manufacturer can run the process with its own internal resources. However, due to the complexity of the legislation and the high cost of mistakes, most companies prefer to run the process with an experienced engineering consultant.
Where does the CE certification process start — in Turkey or in the EU?
The process starts with the product itself, regardless of the manufacturer's country. Even if the manufacturer is based in Turkey, the same directive and standard requirements apply if the product is intended for the EU market.
Should a prototype be tested before obtaining CE certification?
Where possible, yes; pre-tests carried out at the design stage allow non-conformities to be identified and corrected before mass production begins, avoiding costly design changes later.
Who grants approval during the CE certification process?
For most product groups, the manufacturer itself runs the process and signs its own declaration of conformity; there is no external approval authority. Only for high-risk product categories is review and certification by a notified body required.
Is a single CE process sufficient for multiple product models?
If there is clear similarity between product families in terms of design, materials and risk profile, a shared technical file and testing approach can be used; however, conformity must still be justified separately for each model.
What should be done after the CE certification process is complete?
The technical file and declaration of conformity must be kept for the period required by law, the file must be updated whenever the product design changes, and it must be kept ready for market surveillance inspections.
How does the CE certification process work for an imported product?
The importer should obtain a copy of the technical file and declaration of conformity from the foreign manufacturer, reasonably verify that the product genuinely conforms as declared, and put its own contact details on the product.
At which stage does the CE certification process usually lose the most time?
In practice, the most time is lost through mid-process revisions caused by an incorrect choice of directive/standard, and through waiting for laboratory test appointments. This is why correct planning at the start of the process is critical.
Conclusion
The process of obtaining CE certification is an engineering discipline that proceeds in the right order: scope analysis, directive and standard selection, risk analysis, the technical file, the required tests, and finally the declaration of conformity and marking. Solid planning at the start of the process prevents costly revisions later on. Manufacturers who want to set the whole process up correctly from the outset can also find a summary overview of the entire flow in our article, The CE Certification Process Step by Step.
If you're not sure where to start on your product's CE journey, let's carry out a pre-assessment together. See our CE consultancy service for more details.
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