EU – MDR – EN – Thermosaver

Stricter Requirements for Medical Devices Under New EU MDR Regulations

With the introduction of the new Medical Device Regulation (MDR), the EU has implemented stricter and more forward-looking oversight of medical devices. The regulation came into effect in 2021. Covering more than 500,000 different medical products, the MDR aims to make the regulation of such devices both simpler and more transparent for customers and users. At the same time, it seeks to make it harder for untrustworthy operators to enter or remain in the medical device sector.

Thermosaver is now classified as a medical device under EU MDR, falling within Risk Class I—the lowest of four risk categories. This classification grants the right to label the product with the CE mark. The CE marking is an important indicator in the market, signaling a product that meets quality and regulatory standards.

In 2022, Thermosaver AS signed a Declaration of Conformity, confirming that the company operates in compliance with the EU MDR standards.

The new EU-MDR sets strict requirements for medical devices