What is meant by “Medical Device”?

According to the definition contained in Legislative Decree No. 46 of 1997, which transposed EU Directive 93/42 into Italian law, a medical device is:

• an instrument

• an apparatus

• an implant

• a substance

• another product

used alone or in combination, including computer software intended for proper functioning, and designated by the manufacturer to be used in humans for the purposes of:

• diagnosis, prevention, monitoring, treatment, or alleviation of a disease

• diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability

• study, replacement, or modification of anatomy or of a physiological process

• control of conception

provided that it does not achieve its principal intended action in or on the human body by pharmacological or immunological means, nor by metabolic process, but whose function may be assisted by such means.

What guarantees are implied by the CE marking of medical devices?

This marking demonstrates compliance with the essential requirements of Legislative Decree 46/97 (implementation of EU Directive 93/42/EEC) for medical devices, and therefore serves as a product certification ensuring:

• functional quality and quality of materials

• control of the manufacturing process and testing phases

• traceability of the device throughout its entire circulation path, from the factory to the final customer

The purchase of a Class 1 medical device allows eligible individuals to benefit from a tax deduction for healthcare expenses (Art. 15, paragraph 1, letter C of the Italian Income Tax Code – TUIR – and Resolution of the Italian Revenue Agency No. 253 of 29/09/2009).

Therefore, the expense incurred for the purchase of such products may be deducted as a healthcare expense for an amount equal to 19% (for the portion exceeding the deductible threshold of €129.11, applied to the total amount of all healthcare expenses incurred) in the income tax return relating to the tax period in which the purchase was made.

To take advantage of this benefit, the following documentation is required:

• A prescription on the letterhead of the attending physician (and/or specialist) certifying the necessity of using the aforementioned products.

• An invoice made out to the taxpayer to whom the expense refers, or a fiscal receipt containing the following data: nature, quality, and quantity of the goods purchased, and the tax code of the recipient.

This documentation must be kept together with the income tax return for at least 5 years.

It should be emphasized that the condition for deducting the expenses incurred must be linked to a pathology proven by the medical prescription, certifying the necessity that justified the expense.

It should also be noted that the purchased product must be included in List 2 of Ministerial Decree No. 332 of 27 August 1999, issued by the Ministry of Health.