Jacoti BV - is certified to the requirements of EN ISO 13485:2016 and of the EU Medical Device Regulation (MDR), and is also registered as a Medical Device Manufacturer at the USA Food and Drug Administration.
Jacoti Hearing Center and Jacoti Hearing Center Pro are Class II FDA listed Medical Device, classified under product code EWO.
As Medical Devices, they are designed, developed and manufactured in accordance with a quality system compliant with 21 CFR Part 820 (United States quality requirements).
The Medical CE Mark indicates that Jacoti ListenApp, Jacoti Hearing Center and Jacoti Hearing Center Pro meet the requirements of Annex IX Chapter I and III of the Medical Device Regulation (EU) 2017/745. This approval is granted by the Notified Body BSI.
EU Medical Device Regulation (EU) 2017/745
This EU Regulation (MDR) is applicable to medical devices, such as instruments, apparatus, appliances, materials, software or other articles to be used for human beings and defines basic requirements, protective measures for health and safety, classification, field incident reports, conformity assessment procedures, clinical testing, designated organisations and CE marking requirements, including Annexes I through XVII. This Regulation is applicable to CE-marked medical devices for export to the European Economic Area EEA (EU + EFTA). It is amending EU Council Directive 93/42/EEC (MDD) and was introduced by the European Union (EU) in an effort to modernize and strengthen the EU legislative framework with the aim of improved patient safety.
EU Council Directive 93/42/EEC (Medical Device Directive)
This EU Directive is amended by Regulation (EU) 2017/745. It is applicable to a similar scope of medical devices to be used for human beings. It entails CE marking requirements, including Annexes I through XII and is applicable to CE-marked medical devices for export to the EEA (EU + EFTA).
ISO 13485:2016 - Medical devices
This is an international standard defined to assist in establishing a worldwide quality management system in the medical device industry, and has been introduced or is being introduced as a regulatory requirement in more and more countries. The establishment of this standard, the initial publication of which took place in July 2003, is based on ISO 9001:2000, with additional requirements specific to medical devices. ‘Customer satisfaction’ and ‘continuous improvement’ which are new to ISO 9001:2000 are referred to in this ISO 13485:2016 as ‘customer focus’ and ‘maintenance of adequacy and effectiveness’ because they were considered as being incongruous with medical devices.
CE marking, EC Declaration of Conformity (full quality assurance system)
The placing of CE markings on medical devices. Several rules must be complied with in order to receive a declaration of conformity. These rules relate not to product verification but to the approval of a quality system for design, manufacture and final inspection.