CE Medical Certification

The CE marking for medical devices is a certification awarded to manufactures who meet relevant product directives issued by the European Union. By conforming to the standards and obtaining the marking, the product would therefore comply with the European health, safety and environmental protection legislation, and hence have clearance to be sold on the market.

Mente is classified as a Class IIa medical device and is regulated under the EU council directive 93/42/EEC on medical devices. As part of the requirements, Mente was tested according to a number of harmonized standards that specify safety requirements of electrical medical devices, electromagnetic compliance (EMC), and medical device software requirements, among others. These included durability and stress tests which were conducted on the device in order to evaluate the product’s attributes and performance under extreme conditions. Even though it’s unlikely that the headband will be exposed to such environments, Mente was successful and was awarded the marking. Building on the ISO 13485 quality management system, the CE marking focuses on the product’s performance, with the regulations being set to ensure quality throughout the product’s life span.

FDA registered

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. This agency aims to protect and promote public health through the regulation and supervision of (among others) food safety, tobacco products, pharmaceuticals, vaccines, medical devices and electromagnetic radiation emitting devices (ERED). The FDA enforces laws and regulations while setting sanitation and safety requirements throughout products and services alike. The FDA is led by the Commissioner of Food and Drugs, appointed by the US President with the advice and consent of the Senate.

Mente is registered with the United States Food and Drug Administration (FDA) as a Neurological Biofeedback Medical Device classified as Class 2 (special controls) under regulation number 882.5050.  This serves as proof that Mente has met the safety and functionality requirements put forth by the regulation board. The certification conforms Mente to Title 21, 807 et seq. of the United States Code of Federal Regulations. Further information can be reviewed directly on FDA’s online database.

Mente Listing Number: D214124