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Does my medical device need RD 219/2013 substance restriction (RoHS) in Spain?

Describe your device to check whether RD 219/2013 substance restriction (RoHS) 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 RD 219/2013 substance restriction (RoHS) check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family: Environmental and battery obligations
Regulatory object: electrical electronic medical device
Maintained rule status: evidence only no separate certificate
Useful product facts: Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

Article 6(1) of Real Decreto 219/2013 prohibits placing electrical and electronic equipment, cables and spare parts on the market above the Annex II concentration values, and article 6(2) applies the restriction to productos sanitarios and monitoring and control instruments placed on the market from 22 July 2014 and to in vitro diagnostics from 22 July 2016. Surveillance is decentralised: article 4(6) leaves the autonomous communities and Ceuta and Melilla to designate their own authorities, while article 4(3) designates the Secretaría de Estado de Telecomunicaciones for telecommunications equipment. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

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

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.

Radiation

X-ray sales and technical assistance company authorisation

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

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 219/2013 arts. 4 and 6 — RoHS restriction and decentralised surveillance

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.