If you manufacture industrial machinery in Spain and are still unclear about what CE marking implies in 2026, this article gives you the concrete answers you need: which regulation applies, when it enters into force, how much it will cost you to prepare and what steps you must take. Straight to the point and no small print.
What is CE marking for machinery and why is it mandatory
CE marking is not a voluntary quality seal: it is the legal passport to place machinery on the European market. Without it, you cannot place your machine on the market or put it into service within the European Economic Area. The marking certifies that the manufacturer has assessed the risks, has applied the required safety measures and has drawn up the relevant technical documentation.
For decades, the legal framework was the Machinery Directive 2006/42/EC, transposed into Spanish law through Royal Decree 1644/2008. This directive will remain valid until 20 January 2027, when it will be replaced on a mandatory basis by Regulation (EU) 2023/1230 on Machinery, published in the Official Journal of the European Union on 29 June 2023.
The shift from directive to regulation is significant: as a regulation, it is directly applicable in all Member States without the need for national transposition, which eliminates differences in interpretation between countries. For SME manufacturers, this means that the European text takes precedence over any complementary Spanish legislation.
The transition from Directive 2006/42/EC to Regulation 2023/1230: key deadlines
Understanding the timeline is essential before talking about costs or processes. Here are the milestones that every manufacturer must have marked in the calendar:
| Date | Regulatory milestone | Practical implication |
|---|---|---|
| 29 Jun. 2023 | Publication of Regulation (EU) 2023/1230 | Text enters into force; transitional period begins |
| Until 20 Jan. 2027 | Coexistence period | Manufacturers may apply Directive 2006/42/EC or the new Regulation (at the manufacturer's choice) |
| 20 Jan. 2027 | Definitive repeal of Directive 2006/42/EC | Only Regulation 2023/1230 applies; all new machinery must comply |
| 2 Aug. 2027 | Deadline for AI systems in machinery (AI Act) | Regulation (EU) 2024/1689 (AI Act) fully applies to high-risk AI systems embedded in machinery covered by EU harmonisation legislation (Annex I of the AI Act) |
Practical conclusion: if you are currently designing a new machinery line, the most prudent course is to align it now with Regulation 2023/1230. If you have machinery already certified under Directive 2006/42/EC that is not substantially modified, that certificate remains valid for units placed on the market before 20 January 2027.
Key changes in Regulation 2023/1230 affecting SME manufacturers
The new regulation is not a mere cosmetic update. It introduces substantial changes that many SME manufacturers are still unaware of:
Digital instructions
For the first time, the Regulation allows instructions for use to be provided exclusively in digital format (without paper) under certain conditions. This opens cost-saving opportunities, but requires the manufacturer to guarantee permanent access for the user.
AI-based safety components
The Regulation introduces specific rules for safety components incorporating artificial intelligence with learning capability. These products are classified as «substantially modified products» when the AI system alters their behaviour after being placed on the market, which may require a new conformity assessment.
Extended scope of application
Regulation 2023/1230 extends the list of covered products compared to the previous directive. In particular, it more explicitly incorporates certain lifting equipment, machinery intended for domestic use that may be operated by non-professional users, and new-generation construction equipment.
Digital declaration of conformity
A EU declaration of conformity in digital format is permitted, although the manufacturer must ensure its accessibility for at least ten years from the date the product was placed on the market.
The CE marking process step by step: what an SME manufacturer must do
The process follows a clear logic. The manufacturer is always ultimately responsible for conformity, even if they rely on an external consultant or a notified body for parts of the process.
From Summum Consultoría, with offices in Valladolid, Burgos, Palencia, Aranda de Duero and Las Palmas, we support SME manufacturers throughout the entire CE marking process, from identifying the harmonised standard to lodging the technical file. These are the usual steps:
- Identification of scope and risk category. Not all machinery follows the same route. Regulation 2023/1230 distinguishes between machinery subject to internal assessment (Module A) and special-category machinery requiring intervention by a notified body (Annex I, high-risk categories).
- Application of harmonised standards. The EN standards of the European Committee for Standardization (CEN/CENELEC) provide presumption of conformity. Their application is not mandatory, but it is the most efficient way to demonstrate compliance with the Essential Health and Safety Requirements (EHSRs) of the Regulation.
- Risk analysis and assessment. This is the technical core of the process. It must be carried out in accordance with standard EN ISO 12100:2010 («Safety of machinery — General principles for design»). The result is a risk assessment report documenting each identified hazard, its estimation and the measures taken.
- Compilation of the technical construction file. The file must contain: a general description of the machine, overall and detailed drawings, risk analysis, standards applied, test results, a copy of the declaration of conformity and instructions for use.
- Drafting the instructions for use. These must be in the official language of the destination country. They are a legal document; errors or omissions in the instructions may lead to civil liability for the manufacturer.
- EU declaration of conformity and affixing the marking. Once the preceding steps are complete, the legal representative signs the EU declaration of conformity and the CE marking is physically affixed to the machine, visibly, legibly and indelibly, with a minimum height of 5 mm.
- Retention of the technical file for ten years. Calculated from the last date of manufacture of the machine. The market surveillance authority (in Spain, coordinated by the Ministry of Industry and Commerce and the regional governments) may request it at any time.
Indicative cost of the CE marking process for an industrial SME
This is the question we are asked most often. There is no single price because the cost depends on several factors: the complexity of the machine, whether prior technical documentation already exists, whether a notified body is required and whether the company has internal staff with the technical training to collaborate in the process.
With those caveats, the indicative market ranges in Spain for 2025–2026 are as follows:
| Machine type / scenario | Indicative external consultancy cost | Notified body cost (if applicable) | Estimated timeline |
|---|---|---|---|
| Simple machine, low risk, Module A (self-declaration) | €2,500 – €6,000 | Not required | 6 – 10 weeks |
| Medium-complexity machine (e.g. packaging line, simple collaborative robot) | €6,000 – €15,000 | Not required (unless Annex I) | 3 – 5 months |
| Special-category machinery (Annex I of Regulation 2023/1230: presses, band saws, etc.) | €8,000 – €20,000 | €3,000 – €12,000 additional | 4 – 8 months |
| Complex machinery or complete integrated line | €15,000 – €40,000+ | Variable depending on body and tests | 6 – 12 months |
Note: these ranges reflect external consultancy market fees in Spain in 2025–2026, obtained from sector references (CECIMO, surveys by machinery manufacturers' associations and publications by accredited notified bodies). They are not Summum's rates. The actual cost always depends on a preliminary analysis of the specific project.
The factors that most increase the cost are: machinery with no prior technical documentation (everything must be built from scratch), machines incorporating electrical panels (requiring additional compliance with the Low Voltage Directive and EMC Directive), the presence of AI components (interaction with the AI Act), export to markets outside the EU with their own requirements (USA, United Kingdom, etc.) and the need for physical testing in an accredited laboratory.
Most common mistakes made by SME manufacturers
After supporting industrial manufacturers for more than eighteen years, at Summum we have identified a recurring pattern of mistakes that extend timelines and increase costs:
- Confusing CE marking with a quality certificate. They are different things. CE marking certifies conformity with essential safety requirements; ISO 9001 certification certifies the manufacturer's quality management system. They can coexist and are complementary, but they are not equivalent.
- Delegating responsibility to the component supplier. If you integrate a machine using third-party components, the CE marking responsibility for the complete assembly falls on you as the manufacturer of the final equipment, not on the sub-component supplier.
- Copying the declaration of conformity from another machine. The declaration is specific to each model. Signing a declaration copied from another file without adapting it can constitute a serious infringement with significant financial penalties.
- Not updating the technical file when the machine is modified. A substantial modification (change of the control system, increase in speed, replacement of safety devices) requires repeating the risk assessment and updating the file.
- Ignoring additional directives that may apply. Many machines are subject to more than one directive or regulation: in addition to the Machinery Regulation, the Electromagnetic Compatibility Directive (2014/30/EU), the Low Voltage Directive (2014/35/EU), the Pressure Equipment Directive (2014/68/EU) or the Construction Products Regulation, among others, may apply.
Market surveillance in Spain: who controls and what penalties exist
In Spain, market surveillance of machinery falls under the Ministry of Industry and Commerce, through the Directorate-General for Industry and Small and Medium-Sized Enterprises, in coordination with the regional industry departments. ENAC (National Accreditation Body) accredits Spanish notified bodies.
Infringements in relation to CE marking are classified under Law 21/1992 on Industry and its implementing regulations. Penalties can range from €6,000 for minor infringements to more than €600,000 for very serious ones. Furthermore, in the event of an accident involving machinery without proper CE marking, the manufacturer's civil liability is greatly aggravated.
If you need support to manage the regulatory compliance of your machinery, contact our Summum Consultoría team: since 2007 we have been helping industrial SME manufacturers complete the process with guarantees and within committed timelines.
Frequently asked questions
Can I manufacture under Directive 2006/42/EC until the end of 2026?
Yes. The transitional period of Regulation (EU) 2023/1230 allows Directive 2006/42/EC to be applied until 20 January 2027. Machines placed on the market under that directive before that date remain valid. However, if you are currently designing new machinery, the most sensible course is to align it now with the Regulation to avoid a new assessment in a few months' time.
Does all industrial machinery require a notified body?
No. Most machines can follow the Module A self-declaration route: the manufacturer assesses conformity on their own (or with the support of an external consultant) and signs the declaration. Only certain types of machinery listed in Annex I of Regulation 2023/1230 — such as band saws for meat, presses with automatic cycle, certain passenger-lifting equipment — require intervention by an accredited notified body.
What happens if I buy second-hand machinery from outside the EU?
If you import a used machine from a third country (non-EU) and put it into service in Spain, you become the manufacturer for the purposes of the Regulation. You are obliged to carry out the full conformity assessment, compile the technical file and issue the declaration of conformity before putting it into operation. This is one of the most critical scenarios with the highest number of incidents in market surveillance.
How long must the technical file be retained?
Regulation (EU) 2023/1230, as the previous directive did, requires the technical file to be retained for at least ten years from the last date of manufacture of the machine. The market surveillance authority may request it at any time during that period; if you cannot present it, the machine is considered non-conforming regardless of whether the CE marking has been affixed.