The new EU-MDR sets strict requirements for medical devices
Through the introduction of the new Medical Device Regulation (MDR), the EU ensures more strict and forward-looking monitoring of medical devices. The directive entered into force on 27 June 2021 after a transition period of 4 years. The scheme covers more than 500,000 different medical products and is intended to make the control of such equipment both easier and more transparent for customers and users. At the same time, the aim is to make it more difficult for unscrupulous actors to operate in the medical device sector.
Thermosaver is categorized as a medical device according to the EU MDR risk class 1. This means that the product is in the lowest of a total of 4 risk categories. With such a categorization comes the right to CE mark the product. This is an important marker in the market, and signals a quality product.
After working to satisfy the requirements of the EU MDR for more than a year, Thermosaver AS was able to sign a Declaration of Conformity, in which the company confirms that it operates in accordance with the standards of the EU MDR.