Medical Device Certification

Medical Device Certification

JoyShop mattresses and products marked as Medical Device are classified as Class I, in accordance with EU Regulation 2017/745 (MDR) — the European regulation governing the safety and performance of medical devices.


What this means in practice

The manufacturer of each certified product issues an EC Declaration of Conformity, which attests to compliance with the essential requirements of EU Regulation 2017/745 regarding safety, materials, and performance. The device is registered with the Ministry of Health, which verifies its correct notification on the Italian market.


How to verify it

Compliance documentation is kept on file by JoyShop and is available as a copy upon written request to info@joy-shop.it, including for verification purposes by the customer or competent authorities. On each certified product page, you will find the device class indicated; the full regulatory reference also appears on the invoice at the time of purchase.


Not all JoyShop products are medical devices

Only models expressly indicated on the product page as "Class I Medical Device" fall under this classification. Other products (e.g., non-certified toppers) are described on the product page with their technical characteristics, without medical claims.


Did you know?

Class I Medical Device mattresses are also 19% tax-deductible as medical expenses in your income tax return. Find out how the deduction works →

Frequently Asked Questions

What does "Class I Medical Device" mean?+

It is the lowest risk classification provided by EU Regulation 2017/745 for non-invasive devices without a measuring function. It indicates that the product has been assessed as compliant with the general safety and performance requirements set out by European legislation.

Who issues the certification?+

The product manufacturer, who assumes responsibility for compliance and handles its registration with the Ministry of Health.

Can I see the compliance document?+

Yes, write to us at info@joy-shop.it indicating the product purchased: we will send you the available documentation.

Does the registration number appear on the invoice?+

Yes, for certified products, the complete wording, including the medical device reference, is stated on the invoice at the time of purchase.