Do you manufacture or import a product that must carry the CE marking before being placed on the European market? We design the shortest path from directive analysis to signing the declaration of conformity.
The CE marking is the mandatory passport for a product to circulate freely in the European Economic Area. It is not issued by any public authority: it is declared by the manufacturer itself — or its authorised representative — after demonstrating that the product meets the essential requirements for safety, health and environmental protection set out in the applicable European directives or regulations. The most common mistake among SMEs is assuming that CE marking is a one-off administrative step; in reality it is a documentary and conformity management system that must be kept up to date every time the product or its manufacturing process changes.
The regulatory landscape is in full transition. The Machinery Directive 2006/42/EC, which has governed the sector for almost twenty years, will be repealed by Regulation (EU) 2023/1230 as of 20 January 2027. The new regulation introduces explicit requirements on AI-based safety functions, cybersecurity for embedded software, and the possibility of submitting technical documentation in digital format. In addition, depending on the product type, other directives may also apply: Low Voltage (LVD 2014/35/EU), Electromagnetic Compatibility (EMC 2014/30/EU), Pressure Equipment (PED 2014/68/EU), Personal Protective Equipment (PPE 2016/425/EU), or, in the healthcare sector, Regulations MDR 2017/745 and IVDR 2017/746. Correctly identifying the full regulatory framework applicable to your product is the first step and, in practice, the one that generates the most errors.
Summum Consultoria accompanies manufacturers and importers from all sectors — industrial machinery, electrical equipment, furniture, work equipment, construction components, class I medical devices — in structuring the technical file, defining which harmonised standards apply, and, when the product falls into high-risk categories, managing the relationship with the notified body. We work from Valladolid, Burgos, Palencia and Las Palmas and, where the process has a significant digital dimension, we coordinate with Summum Sistemas on document management or traceability.
We identify all European directives and regulations affecting the product (or product range), determine whether involvement of a notified body is required, and establish the harmonised standards that generate a presumption of conformity. We deliver an applicability report before starting any documentary work.
We review the design, materials and processes against the essential requirements of each directive. Where applicable, we carry out or coordinate the risk assessment in accordance with EN ISO 12100 (machinery) or the methodology required by the sectoral directive. We identify gaps and define the technical actions needed to close them.
We structure the complete technical file: general product description, assembly and detail drawings, list of standards applied, test results and calculations, instructions for use and maintenance. The file must be kept for at least ten years from the date the last unit was placed on the market.
We draft and co-sign (together with the manufacturer's legal representative) the EU Declaration of Conformity, which lists the applicable directives, the harmonised standards applied, and, where relevant, the notified body number. From that point the product may bear the CE marking and be sold throughout the EEA. We also advise on adaptation to Regulation 2023/1230 for manufacturers who must transition before January 2027.
The operational detail: what we deliver as part of the work and what we keep alive afterwards.
Regulatory applicability report
Document identifying all European directives and regulations affecting the product, the available conformity assessment modules, and whether a notified body is required.
Risk analysis
Systematic hazard assessment in accordance with EN ISO 12100 or another relevant methodology, with a record of risk-reduction measures and their effectiveness.
Structured technical file
Complete documentary folder (descriptions, drawings, standards applied, tests, instructions) ready to be presented to the market surveillance authority if required.
EU Declaration of Conformity
Drafting of the legal document that the manufacturer signs to take responsibility for the product's conformity with the applicable directives.
Review of instructions for use
Adaptation of the product manual to the linguistic and content requirements imposed by each directive for the destination countries within the EEA.
Transition planning for Regulation 2023/1230
Roadmap for machinery manufacturers who must adapt their conformity system before 20 January 2027, including assessment of the new AI and cybersecurity requirements.
CE marking for an industrial product may intersect with digital document management (Summum Sistemas) or information security requirements if the equipment incorporates connected software (Summum Calidad, ISO 27001).
When non-compliance with CE marking rules can lead to criminal liability for company directors, criminal compliance closes the legal risk perimeter.
View service → calidadAn ISO 9001 quality management system ensures consistency in the manufacturing process and strengthens the documentary evidence required by the CE marking technical file.
View service → sistemasWhen the product includes embedded software or connectivity, Summum Sistemas evaluates the technical architecture and helps meet the cybersecurity requirements of Regulation 2023/1230.
View service →CE marking means the manufacturer declares that the product meets the essential requirements of the applicable European directives. In most cases it is a self-declaration backed by a technical file, not a third-party certification. For higher-risk products (upper categories of machinery, category III PPE, class II or higher medical devices) an accredited notified body does intervene to verify conformity.
Market surveillance authorities (in Spain, the DGIPYME or regional industrial authorities) may order the product's withdrawal from the market, impose financial penalties, and seek civil or even criminal liability against the manufacturer or importer. Since 2021, Regulation (EU) 2019/1020 has strengthened the powers of control authorities and the obligation of economic operators to cooperate with them.
Regulation (EU) 2023/1230 entered into force on 19 July 2023 and becomes mandatory from 20 January 2027. Until that date it coexists with Directive 2006/42/EC: manufacturers may choose to comply with the current directive or anticipate the transition to the new regulation. Summum Consultoria recommends beginning planning now if your product development cycle exceeds twelve months.
Products covered by a European directive or regulation that requires it need CE marking: machinery and installations, low-voltage electrical equipment, radio equipment, pressure equipment, personal protective equipment, toys, medical devices, construction products, civil explosives, lifts, and recreational craft, among others. A single product may fall under several directives simultaneously.
Yes. Regulation (EU) 2019/1020 establishes that when the manufacturer is outside the EEA and has no authorised representative in the Union, the importer takes on the manufacturer's obligations. A distributor may also become responsible if it markets the product under its own name or introduces substantial modifications. We advise both domestic manufacturers and importers of products from third countries.