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Does my medical device need X-ray sales and technical assistance company authorisation in Spain?

Describe your device to check whether X-ray sales and technical assistance company authorisation may apply, why, what facts are missing, and which official source to review.

8 maintained routes11 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this X-ray sales and technical assistance company authorisation check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: x ray equipment supplier or service company
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Real Decreto 1085/2009 art. 3(a) requires companies that sell and provide technical assistance for X-ray equipment to be authorised by the competent body of the Autonomous Community after a favourable report from the Consejo de Seguridad Nuclear; the authorisation is recorded in the corresponding central register and is valid throughout Spain on the terms recorded there. Art. 7 separately restricts placing on the market and putting into service to X-ray equipment that also complies with the medical device rules, so the supplier authorisation sits alongside, not instead of, the device conformity route.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Spain routes to check

Check every Spain route →

Electrical safety

MDR electrical safety in place of the Low Voltage Directive

Evidence is normally handled inside the medical-device registration route.

EMC

MDR electromagnetic compatibility in place of the EMC Directive

Evidence is normally handled inside the medical-device registration route.

Wireless / radio

RD 188/2016 radio equipment and the CNAF use condition

Applies when the product, feature, component, or use is in scope.

Environmental / battery

RD 219/2013 substance restriction (RoHS)

Evidence may be required, but the matrix does not identify a generic separate certificate.

Environmental / battery

RII-AEE producer registration

Applies when the product, feature, component, or use is in scope.

Environmental / battery

Batteries Regulation with the implementing real decreto still in consultation

A transition is identified; the applicable date and current status must be checked.

Radiation

Autonomous Community X-ray installation declaration and registration

Applies to the facility, operator, or installation rather than only the product.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

BOE (Agencia Estatal Boletín Oficial del Estado)

Real Decreto 1085/2009 on installing and using medical diagnostic X-ray equipment

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Spain scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Spain?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.