Useful information about medical devices

WHAT IS A MEDICAL DEVICE?

According to Council Directive 93/42/EEC, “medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
– Diagnosis, prevention, monitoring, treatment or alleviation of disease.
– Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.
– Investigation, replacement or modification of the anatomy or of a physiological process.
In memorandum no. 20/E of 13 May 2011, the Italian Revenue Agency stated that there is no specific list of tax deductible medical devices that can be checked.

IN WHICH CIRCUMSTANCES ARE MEDICAL DEVICES TAX DEDUCTIBLE?

The situation varies from one country to the next, but taxpayers can normally deduct medical devices if the invoice provides:
– Details of the person who paid.
– A clear description of the medical device, which must have the CE marking placed on it by the manufacturer.

IN SHORT, WHAT DOCUMENTS ARE REQUIRED FOR DEDUCTIONS? (THE DEDUCTIBLE AMOUNT VARIES FROM COUNTRY TO COUNTRY: IN ITALY IT IS 19%)

By way of example, three documents are required in Italy:
– A copy of the invoice with the necessary details (see previous question).
– A copy of the medical prescription stating why the medical device is necessary or a self-certification note describing the product in question and the condition or purpose for which the medical device was purchased.
– A copy of a personal identity document.

HOW IS THE 19% CALCULATED IN ITALY?

The calculations for the total deducible amount in Italy take into account the overall amount invoiced (including VAT) for the medical device(s) in question.


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