Makian M-RX1 X-ray Equipment Approved: What Industrial Companies Must Do in 2026

Key data

If your company uses, imports, or distributes the Makian M-RX1 X-ray equipment, this resolution affects you as of June 20, 2026. The Directorate General for Energy Planning and Coordination has granted type approval NHM-X403 to the AMD Color Sorter KXA6-G Pro X-ray generator equipment, marketed under the Makian brand as model M-RX1, intended for inspection of unpackaged products in industrial environments.

Type approval is the essential prerequisite step for radioactive equipment to operate legally in Spain, but it is not the only requirement. Companies that use it or place it on the market must comply with a set of technical and documentary obligations that come into force immediately.

What does this regulation establish?

The resolution formalizes the type approval of the equipment and establishes the technical and documentary conditions under which it can operate in Spain. The requirements are grouped into four blocks:

Additionally, the resolution explicitly clarifies what it does not cover: type approval NHM-X403 does not authorize manufacturing, marketing, or provision of technical assistance on the equipment. These activities require additional specific authorizations under Royal Decree 1217/2024, which regulates nuclear and radioactive installations in Spain.

Economic and operational impact

The impact is not a fine or a new tax, but a set of recurring operational costs that companies must budget for if they want to operate this equipment in full legal compliance:

• Annual maintenance contract: mandatory with an authorized company to perform the minimum annual review and periodic verifications. The cost will depend on the authorized provider, but it is a recurring expense that must be planned.
• Documentation in Spanish: if the equipment is imported with manuals in another language, the responsible company must ensure the translation and availability of the operating manual and maintenance program in Spanish.
• Marking and signage: the equipment must bear indelible marking with technical data and radioactive signage. If the equipment is already in use without this marking, it must be corrected.
• Additional authorizations for marketers: those who sell or provide technical assistance on the M-RX1 must process separate authorizations, which involves additional time and administrative cost.

The real economic risk is not in this resolution itself, but in operating the equipment without complying with the requirements of RD 1217/2024: an inspection that detects non-compliance in radiological safety can result in suspension of activity and sanctions under the radioactive installations regulation.

Who does it affect?

• Companies using the Makian M-RX1: any company that uses this equipment to inspect unpackaged products in its production or quality control process.
• Importers: companies that introduce this equipment into Spain from third countries, responsible for ensuring documentary and marking compliance.
• Distributors and marketers: those who place the equipment on the Spanish market need additional authorizations not covered by this resolution.
• Technical assistance companies: those providing technical service on this equipment must have specific authorization and be authorized companies to perform maintenance and periodic verifications.
• Manufacturers: type approval is necessary but not sufficient; manufacturing requires additional authorization.

Practical example

An agribusiness company that uses the Makian M-RX1 equipment to inspect unpackaged products on its production line must, as of June 20, 2026:

1. Verify that the equipment bears indelible marking with its technical data (maximum voltage: 80 kV, current: 8 mA, power: 350 W) and the required radioactive signage.
2. Ensure that it has the operating manual and maintenance program in Spanish.
3. Contract with an authorized company for the annual review of the equipment and schedule the corresponding periodic verifications.
4. Check that the dose on the external surface of the equipment does not exceed 1 μSv/h, which must be documented in the reviews.

If this company also distributes the equipment to third parties or provides technical assistance, it will need to process additional authorizations with the competent authority, since NHM-X403 approval does not cover those activities.

What should companies do now?

1. Verify equipment marking: check that the Makian M-RX1 bears indelible marking with the required technical data and radioactive signage. If not, contact the supplier to correct it.
2. Review available documentation: ensure you have the operating manual and maintenance program in Spanish. If they are in another language, request the Spanish version from the manufacturer or importer.
3. Contract annual maintenance: identify and contract an authorized company to perform the minimum annual review and periodic verifications of the equipment.
4. Measure and document external dose: verify that the dose on the external surface of the equipment does not exceed 1 μSv/h and document it for future inspections.
5. Process additional authorizations if applicable: if the company manufactures, markets, or provides technical assistance on this equipment, initiate procedures to obtain the specific authorizations required by RD 1217/2024.
6. Review overall compliance with RD 1217/2024: this resolution is framed within the nuclear and radioactive installations regulation; it is advisable to audit the company's complete compliance with that 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-2026-13446