Key data
| Regulation | Resolution of 31 August 2026, from the Directorate General for Industrial Strategy and Small and Medium-sized Enterprises |
|---|---|
| Publication | 9 September 2026 |
| Entry into force | 9 September 2026 |
| Affected parties | Industrial manufacturers, testing laboratories, certification bodies, transport and telecommunications companies |
| Category | Business Regulation |
| Year | 2026 |
| Issuing bodies | CEN, CENELEC and ETSI |
| Spanish denomination | UNE Standards |
If your company manufactures industrial products, operates testing laboratories or certifies products for the European market, you have an immediate obligation: review the normative references in your technical files and replace the annulled versions. The Resolution of 31 August 2026 from the Directorate General for Industrial Strategy and Small and Medium-sized Enterprises publishes the official ratification of CEN, CENELEC and ETSI standards as Spanish UNE standards corresponding to August 2026.
The effect is immediate: previous versions of these standards are annulled from the publication date, 9 September 2026.
What does this regulation establish?
The resolution ratifies as Spanish UNE standards the European standards approved by the three European standardization bodies during August 2026. Below are all the affected areas and standards:
| Subject area | Standard / Series | Description |
|---|---|---|
| Medical devices — AI | CEN Standard (no number published in summary) | Risk management with artificial intelligence in medical products |
| Medical devices — Processing | CEN Standard (no number published in summary) | Processing of reusable medical products |
| Public transport | NeTEx (data model) | Data models for information exchange in public transport |
| Pressure equipment not subject to flame | Complete EN 13445 series (updated) | Complete update of the series of standards for pressure equipment without flame |
| ICT Cybersecurity | EN 17640 | Cybersecurity requirements for ICT products |
| Railway applications | CEN/CENELEC Standards (no number published in summary) | Technical requirements for railway sector applications |
| TETRA Telecommunications | ETSI Standards | Standards for TETRA communication networks (Terrestrial Trunked Radio) |
| Electronic signatures | ETSI Standards | Technical standards for electronic signatures |
The mechanism is the usual one in technical standardization: when a European standard is ratified as UNE, the previous national version is automatically annulled. There is no coexistence period unless the standard itself expressly establishes one.
Economic and operational impact
The impact is not abstract regulatory: it directly affects the validity of the technical documentation of products circulating in the European market. These are the concrete risks:
- Loss of CE marking conformity: If a technical file references an annulled standard, the product may cease to be considered compliant with the essential requirements of the applicable directive or regulation.
- Blocking in audits and certificate renewals: Notified bodies will require updated references in the next surveillance audits or renewals.
- Cost of updating technical documentation: Reviewing and updating technical files, internal procedures, instructions for use and declarations of conformity has a real cost in engineering and quality management hours.
- Risk in public procurement: Public transport contracts (NeTEx) or telecommunications (TETRA) that require regulatory compliance may be compromised if obsolete versions are referenced.
In the case of the EN 13445 series (pressure equipment), the complete update of the series implies potentially reviewing multiple parts of the standard, which multiplies the adaptation effort for manufacturers of pressure equipment.
Who does it affect?
- Medical device manufacturers: Must update technical files that reference AI standards in risk management and processing of medical products.
- Manufacturers of pressure equipment not subject to flame: Affected by the complete update of the EN 13445 series.
- Public transport companies: Must verify that their data exchange systems comply with the updated NeTEx model.
- ICT and cybersecurity companies: The updated EN 17640 standard affects manufacturers and evaluators of ICT products with cybersecurity requirements.
- Railway sector: Manufacturers and operators that certify rolling stock or infrastructure under CEN/CENELEC standards.
- TETRA network operators: Security bodies, emergency services and companies with private radio communication networks.
- Electronic signature service providers: Qualified providers and companies that integrate electronic signatures in their processes.
- Testing laboratories and certification bodies: Must update testing procedures and evaluation criteria that reference annulled standards.
Practical example
A Spanish manufacturer of pressure equipment not subject to flame currently has its declaration of conformity and technical file referencing previous versions of the EN 13445 series. Following the publication of this resolution on 9 September 2026, those versions are annulled.
In its next surveillance audit with the notified body, the auditor will detect that the normative references in the technical file do not correspond to the current versions. The result may be a non-conformity that requires updating all technical documentation before the next visit, with the cost of engineering hours and the risk of temporary suspension of the certificate if the non-conformity is considered major.
The correct action is to anticipate: review now which parts of the EN 13445 series have been updated, identify the relevant technical changes and update the technical file before the audit arrives.
What should companies do now?
- Identify which standards affect your activity: Review the table of affected areas (medical devices, EN 13445, EN 17640, NeTEx, TETRA, electronic signatures, railway) and determine which ones are present in your technical documentation.
- Audit technical files and declarations of conformity: Locate all references to previous versions of the now annulled standards in your technical files, internal procedures and instructions for use.
- Acquire the new versions of the standards: UNE standards are acquired through UNE (Spanish Association for Standardization). Prioritize those with the greatest impact on your certification.
- Analyze relevant technical changes: It is not enough to change the version number in the document. Verify if the technical requirements have changed and if your product or process remains compliant.
- Update technical documentation: Modify technical files, declarations of conformity and testing procedures with updated references.
- Communicate with your notified body: If you have third-party certification, proactively inform your notified body of the updates made before the next audit.
Frequently asked questions
When do the new UNE standards from August 2026 come into force?
The standards ratified by the Resolution of 31 August 2026 came into force on the same day as their publication in the BOE: 9 September 2026. There is no transitional period unless the standard itself expressly establishes one.
What happens if my technical file continues to reference the previous standard?
Previous versions of the standards ratified in August 2026 are annulled. A technical file that references an annulled standard may be considered non-compliant by the notified body in the next audit, which may result in a non-conformity and, in serious cases, suspension of the certificate or CE marking of the product.
Which sectors need to update their documentation most urgently?
The sectors with the greatest urgency are: medical device manufacturers (AI standards in risk management and processing of medical products), manufacturers of pressure equipment not subject to flame (complete updated EN 13445 series), ICT companies with products certified under EN 17640, and TETRA network operators and electronic signature service providers.
Where can I purchase the new versions of UNE standards?
UNE standards are purchased through UNE (Spanish Association for Standardization), on its official website une.org. They can also be consulted through the European standardization bodies CEN, CENELEC and ETSI for the original EN versions.
Does the EN 17640 standard affect all technology companies?
The EN 17640 standard specifically affects manufacturers and evaluators of ICT products with cybersecurity requirements. It does not apply to all technology companies, but to those whose products require evaluation or certification of cybersecurity under this European standard.
Official source
Consult complete regulation in official source
Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-18888
