Elitac Wearables has registered the BalanceBelt, a unique, wearable treatment for patients with severe balance disorders, officially as a Class 1 Medical Device with the European Union Medical Device Regulation (MDR). Adherence to the MDR norms attests that the BalanceBelt was developed according to EU MDR patient safety standards and product quality and reliability norms.
15 November 2021, Utrecht (Netherlands) – The BalanceBelt is meant for people suffering from Bilateral Vestibular Hypofunction or Loss (BVH/BVL). These disorders, in which the balance organs in both ears are either impaired or completely non-functional, did not have any sustainable or non-invasive treatment options previously.
Facilitating international distribution
Explaining the decision, Erland Fuglsbjerg, Managing Director of Elitac BalanceBelt B.V. said, “Since we launched the BalanceBelt, we have had growing international interest from patients, physicians and distributors. However, in regions that accept the CE mark, the Class 1 Medical Device classification is required for physicians to prescribe the solution to patients. This registration allows us to enter all the markets that accept Class 1 Medical Devices with a CE mark and reduces many of the costs associated with importing a medical device. This way, we can make the belt available to many more people suffering from BVH/BVL.”
Increased focus on developing medical wearables
The BalanceBelt was developed by Elitac Wearables in collaboration with renowned vestibular expert Prof. Dr Kingma and the Maastricht UMC+ (NL). It is one of several medical wearables developed by the Netherlands-based wearables development company. The company specialises in integrating textiles and electronics, with a particular focus on haptic feedback and sensors.
The BalanceBelt’s MDR registration illustrates Elitac Wearables’ increased focus on developing more wearable medical devices in the future. Co-founder and CEO Merijn Klarenbeek explained, “We see unparalleled potential for wearable technology to improve the lives of people suffering from medical conditions and the standard of medical care.”
“That’s why we are taking steps to achieve ISO 13485 certification for our company. Developing wearables in adherence to this international standard will help ensure that we consistently keep designing, developing and producing medical wearables that are safe to use. We are currently reviewing all our processes and expect to achieve the ISO 13485 certification for our company during the course of 2022.”
“As for the BalanceBelt, its registration as a Class 1 Medical Device is an important step toward helping as many BVH/BVL patients as possible benefit from this unique treatment.”