For medical devices, a VAT rate of 8 % applies. However, it should be clarified that, under the Goods and Services Tax Act, medical devices within the meaning of the Law of 20 May 2010 on medical devices (OJ 2019, item 2019) are taxed at a rate of VAT of 8 % regardless of the CN. 175, 447 and 534) authorised in the territory of Polish.
What does that mean?
This means that a product subject to a VAT rate of 8 % should meet the definition of a medical device in the Medical Devices Act and undergo the entire procedure for placing such a product on the market.
Accordingly, the manufacturer should carry out a conformity assessment process for the medical device (involving a notified body in the case of higher classes of devices), culminating in a declaration of conformity confirming that the applicable essential requirements have been demonstrated. If, on the other hand, the participation of a notified body was required in the conformity assessment process, a certificate issued by that body shall be required in addition to the placing on the market of the product.
Furthermore, in order to lawfully place a product on the market, it should be properly labelled (including the CE mark, which is affixed only after the conformity assessment process has been carried out) and should be accompanied by instructions for use. Exceptionally, no instructions for use are required for class I and Ii(a) medical devices if such devices can be safely used without such instructions.
Only the fulfilment of all the above requirements will give rise to the application of a VAT rate of 8 %.
Is the equipment of medical devices also subject to a VAT rate of 8 %?
The VAT rate of 8 % will also apply to the equipment of a medical device, i.e. an article which, without being a medical device, is specifically intended by the manufacturer for use together with a medical device in order to be able to use it in accordance with the intended use.
Supreme Administrative Court in its judgment of 30 July 2020 (ref. I FSK 2120/19), pointed out that, since the Law on medical devices introduces a broader concept of medical devices for the purposes of other laws, including 'medical device equipment', there is no justification for narrowing that concept for the purposes of the goods and services tax.
Medical devices ≠ personal protective equipment
At the same time, we point out that personal protective equipment or personal protective equipment is a category of products separate from medical devices.