THE HEARX GROUP OFFICIALLY RECEIVES CE MARKING
The hearX Group is pleased to announce that we’ve officially received our CE (Conformité Européenne) certification for hearTest™. This most recent certification joins the mantle next to our other certifications and registrations including FDA (Food and Drug Administration), ISO 13485 (International Standards Organisation), and SAHPRA (South African Health Products Regulatory Authority), for this product. The CE mark is a legal requirement to place a device on the market in the European Union (EU).
CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the EU. Compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type.
hearTest™ is a smartphone pure tone audiometry solution, offering advanced features with cloud-based data management. The process for hearTest™ to become CE certified started mid 2016 and involved implementing, certifying and maintaining a quality management system (ISO 13485) and performing extensive product testing. In addition, clinical evaluation, the submission of reports and technical files, and undergoing various audits by a notified body formed part of the process.
The CE mark provides the benefit of free movement of a product throughout the 30 member countries of the European Free Trade Area (EFTA) and provides an extra layer of assurance to our customers that hearTest™ conforms to the strictest safety and performance requirements. The hearX Group looks forward to the opportunities that await in Europe for hearTest™, as we continue on our mission to provide healthy hearing for everyone, everywhere.