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.

Recognized products and services are ideal for people with allergies and intolerances. They offer significant added value and simplify the daily lives of those affected, because no matter what area of ​​life, having transparent information is valuable and helpful when it comes to allergies. It's also important to us that recognized products are not significantly more expensive than similar products or services for people without allergies. The ECARF quality label was developed by the ECARF Foundation in close collaboration with experts from various fields. It guarantees tested quality and active support for consumer decisions in over 10 languages.

You can find more information about the ECARF quality label here.

OEKO-TEX® Standard 100

The OEKO-TEX® Standard 100 is an independent testing and certification system for the entire textile chain, from raw materials to semi-finished and finished products at all stages of processing.

Examples of certifiable items include: raw and dyed/finished yarns, raw and dyed/finished woven and knitted fabrics, finished articles (all types of clothing, home textiles, bed linen, terry cloth products, textile toys, etc.).

Criteria

Testing for harmful substances includes:

• substances prohibited by law

• substances regulated by law

• chemicals known to be harmful to health (but not yet regulated by law)

• as well as parameters to safeguard human health

In general, the requirements go well beyond existing national legislation.

Laboratory analyses and product classes

OEKO-TEX® testing for harmful substances is always based on the actual intended use of the textile article. The more intensive the contact of a product with the skin, the stricter the ecological requirements it must meet.

Accordingly, four product classes are distinguished:

• Product Class I:
  Textile products and textile toys for babies and young children up to three years old (clothing, toys, crib/bed linen, terry cloth items, etc.).

• Product Class II:
  Textile products used close to the skin (underwear, bed linen, T-shirts, etc.).

• Product Class III:
  Textile products not used close to the skin (jackets, coats, etc.).

• Product Class IV:
  Materials for furnishings (curtains, tablecloths, wall and floor covering textiles, etc.).

Certification

The prerequisite for textile product certification according to OEKO-TEX® Standard 100 is that all components of an item must, without exception, meet the required criteria. This means that, in addition to the outer fabric, elements such as sewing threads, linings, prints, etc., as well as non-textile accessories like buttons, zippers, rivets, etc., must also comply.

Regular testing of materials allows us to maintain the high quality standards of our products, ensuring the peace of mind of our customers.

Recent studies report a positive allergy test rate for latex of approximately 3.5% in the general population, rising to 26% among asthmatics. (Source: FDA)