In Europe, burn creams qualify as medical devices if they have a medical purpose, like healing or infection prevention. These products must meet EU medical device legislation. The RECELL System and NexoBrid illustrate this classification, highlighting their effectiveness and safety for burn care.
These creams typically contain specific ingredients that promote healing or provide pain relief. If a burn cream is classified as a medical device, it must meet rigorous safety and efficacy standards. This includes undergoing clinical evaluations and obtaining CE marking, which demonstrates compliance with EU regulations.
Manufacturers must clearly define the indications for use and label the products accordingly. Certain formulations may be classified as cosmetics instead of medical devices if they are intended for skin care without specific claimed medical benefits. The distinction is crucial for consumers and healthcare professionals when selecting appropriate burn treatment options.
Understanding the classification and guidelines surrounding burn creams is essential. This knowledge helps ensure that individuals use the correct products for burn treatment. In the next section, we will delve deeper into the specific criteria used to classify burn creams within the regulatory framework.
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