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V1887-21 ·16 June 2021 ·consulta-vinculante Medium impact
Tax

0% VAT rate for SARS-CoV-2 diagnostic products requires compliance with European health regulations

A company has requested clarification on whether its COVID-19 sample collection kit qualifies for the 0% VAT rate. The Directorate-General for Taxes (DGT) has ruled that this rate applies only to in vitro diagnostic medical devices that comply with Directive 98/79/EC or Regulation (EU) 2017/746.

In 6 key points

How it affects those involved

Companies manufacturing or distributing diagnostic kits must ensure full regulatory compliance with EU medical device standards to benefit from the 0% VAT rate.

Lifecycle

2021-06-16PublishedPublished in the BOE
Official text Based on BOE data (boe.es). Information, not advice.

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This analysis is informational only and does not constitute legal advice or create a client-adviser relationship. BM Consulting.
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