Doctrine by topic · DGT Observatory

Medical Products: DGT doctrinal evolution

How the DGT's position on this topic has evolved, and the rulings it rests on.

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How the DGT's position has evolved

Stable position High confidence 37 rulings · 2015–2023

Current position

The reduced rate of 10% applies to products designed to alleviate or treat deficiencies for the personal and exclusive use of persons with physical, mental, intellectual, or sensory deficiencies. To this end, they must be considered prostheses, orthoses, or surgical implants according to current regulations. In vitro diagnostic medical devices for SARS-CoV-2 that do not meet the requirements for the reduced rate are taxed at 21%. Non-reusable plastic packaging containing medical products is exempt from the packaging tax.

The DGT's position remains constant regarding the application of the 10% reduced rate based on the purpose of alleviating deficiencies for personal use. A diversification of the subject matter is observed towards the exemption of plastic packaging and the temporary regulation of a 0% rate for COVID-19 products. There are no changes in the interpretation of the design requirements for the reduced rate.

Turning points

  1. V2684-19

    Clarifies that masks for immunocompromised individuals are taxed at 21% as they do not meet the requirement of being designed for the personal and exclusive use of persons with deficiencies.

  2. V0544-23

    Introduces the exemption in the packaging tax for those containing medical products in accordance with Regulation (EU) 2017/745.

Analysis based on 36 of 37 rulings with a stated position. Updated 23 September 2026.

Rulings on this topic

24
V3011-23 20 Nov 2023

Refund of plastic packaging tax may be requested if exempt use is proven

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
envases de plástico no reutilizablesexencióndevolución del impuestoadquisición intracomunitariadestino efectivo Ley 7/2022LGT — Ley 58/2003 General Tributaria art. 66
Affects CompanyExpat · Non-residentIndividual
V1494-23 1 Jun 2023

Self-assessment for plastic packaging tax must be filed even if acquisitions are exempt

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
impuesto especial sobre envases de plástico no reutilizablesexenciónautoliquidaciónlibro registro de existenciasadquisición intracomunitaria Ley 7/2022LGT — Ley 58/2003 General Tributaria art. 17
Affects CompanyExpat · Non-residentIndividual
V1006-23 25 Apr 2023

Plastic packaging for medicines and medical devices may be exempt from special tax

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
envases de plástico no reutilizablesexenciónadquisición intracomunitariamedicamentosproductos sanitarios Ley 7/2022LGT — Ley 58/2003 General Tributaria art. 66
Affects CompanyExpat · Non-residentIndividual
V0971-23 20 Apr 2023

Empty plastic inhalers are subject to packaging tax but may be exempt

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
envases no reutilizablesámbito objetivoexenciónproductos sanitariosdeclaración previa Ley 7/2022Real Decreto 1055/2022
Affects CompanyExpat · Non-residentIndividual
V0953-23 20 Apr 2023

Non-taxpayer purchasers may claim refunds on plastic packaging tax under certain conditions

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
impuesto especial sobre envases de plásticodevolución del impuestoproductos sanitariosadquirente no contribuyenteterritorio de aplicación Ley 7/2022LGT — Ley 58/2003 General Tributaria art. 105.1
Affects CompanyExpat · Non-residentIndividual
V0544-23 7 Mar 2023

Import of plastic packaging for medical devices may be tax-exempt

SG de Impuestos Especiales y de Tributos sobre el Comercio Exterior y sobre el Medio Ambiente
impuesto sobre envases de plásticoproductos sanitariosenvases no reutilizablesexenciónimportación Ley 7/2022Reglamento (UE) 2017/745
Affects CompanyExpat · Non-residentIndividual
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