Gilardoni X-ray Equipment Authorized in Spain: What User Companies Must Comply with in 2026

Key data

Companies that operate or plan to acquire industrial X-ray equipment for package inspection have had, since 19 October 2026, a clear regulatory reference: the General Directorate of Energy Planning and Coordination has granted type approval NHM-X406 to Gilardoni S.p.A. equipment imported by Palex Medical SAU. This is not a minor procedure: it defines exactly what conditions must be met by those who use, distribute or provide technical support to this equipment in Spanish territory.

The resolution, published in the BOE on 19 October 2026, enters into force on that same day and directly affects importers, distributors and user companies of this equipment.

What does this regulation establish?

The resolution grants type approval to two families of X-ray generating equipment from Italian manufacturer Gilardoni S.p.A., intended for package inspection in industrial environments. The authorized models and their technical characteristics are:

The approval imposes a series of technical and documentary obligations that must be met at all times:

• Indelible marking on the equipment, with permanent identification of the model and manufacturer data.
• Technical documentation in Spanish, including complete operating manual.
• Maintenance program with annual review as a minimum.
• Formally designated personnel to operate the equipment.
• Technical assistance provided exclusively by a company authorized for radiological activities.
• Periodic verification that the dose at 0.1 m from the equipment surface does not exceed 1 μSv/h.

A critical point that the resolution makes very clear: type approval NHM-X406 does not by itself enable manufacturing, marketing or providing radiological technical assistance. Each of these activities requires additional specific authorizations.

Economic and operational impact

For user companies, the impact is not just documentary. Complying with this resolution involves concrete operational costs and changes in internal management:

• Contracting authorized technical assistance: Any maintenance provider will not do. It must be a company with specific authorization for radiological activities, which reduces the market of available providers and may increase the cost of service.
• Mandatory annual review: The maintenance program must include at least one review per year. Skipping this requirement exposes the company to regulatory non-compliance in radiological safety matters.
• Formal designation of operator personnel: It is not enough for someone to "know how to use" the equipment. There must be an express and documented designation.
• Periodic dose verification: The company must be able to prove that the dose at 0.1 m from the surface does not exceed 1 μSv/h. This requires measurements and documentary record.
• Documentation in Spanish: If the equipment was purchased with manuals in another language, the Spanish version must be requested from the importer (Palex Medical SAU).

For importers and distributors, the resolution clarifies that type approval does not replace marketing authorizations or radiological technical assistance authorizations, which must be processed separately with the competent bodies.

Who does it affect?

• User companies of Gilardoni XE-S, HP1 or HP2 equipment for package inspection (logistics, customs, industrial security, quality control).
• Importers of this equipment in Spain, with Palex Medical SAU as the designated official importer.
• Distributors that market these models: they need additional radiological marketing authorization.
• Technical assistance companies that provide maintenance for this equipment: they must have specific authorization for radiological activities.
• Radiological safety managers in facilities that already have this equipment: they must verify that their documentation and protocols comply with the resolution requirements.

Practical example

A logistics company that operates a Gilardoni NDT Scanner HP2 equipment for package inspection in its warehouse must, as of 19 October 2026:

1. Verify that the equipment bears indelible marking with the manufacturer and model data.
2. Request from Palex Medical SAU (official importer) the operating manual in Spanish if you do not have it.
3. Formally designate in writing the authorized personnel to operate the equipment.
4. Contract a company with radiological authorization for annual maintenance, not a generic technician.
5. Perform and record a dose measurement to prove that 1 μSv/h at 0.1 m from the equipment surface is not exceeded.

If the company also distributes this equipment to third parties or provides external technical service, it must process additional authorizations, since NHM-X406 approval does not cover those activities.

What should companies do now?

1. Identify affected equipment: Check if the facility has Gilardoni XE-S, NDT Scanner HP1 or HP2 models. NHM-X406 approval applies exclusively to these models.
2. Review technical documentation: Verify that you have the operating manual in Spanish and that the equipment bears indelible marking as required.
3. Formalize personnel designation: Document in writing which people are authorized to operate the equipment.
4. Contract authorized technical assistance: Ensure that the maintenance provider has authorization for radiological activities. If the current one does not have it, find an alternative.
5. Schedule annual review: Include in the maintenance calendar the mandatory review with a minimum annual frequency.
6. Measure and record the dose: Perform a dose measurement at 0.1 m from the surface and document that it does not exceed 1 μSv/h. Repeat periodically and keep records.
7. Verify additional authorizations if you market or provide service: If the company distributes this equipment or provides technical assistance to third parties, process the specific required authorizations, since type approval does not cover them.

Official source

Consult complete regulation in official source (BOE-A-2026-21765)

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-2026-21765