The CE marking allows the manufacturer to freely circulate their product throughout the countries of the European Economic Area (EEA). The great benefit for them is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA. In addition, by implementing these requirements the product will be safer for the user and this also reduces damage and liability claims. 

The Medical Device Directive (93/42/EEC), according to which our platform is certified, applies to medical devices and their accessories placed in the EU market. Medical devices are defined as any instrument, apparatus, appliance, software, implant, reagent, material, or another article intended to be used for medical purposes, such as medical diagnosis & disease monitoring. 

eHealthPassTM is a multifunctional platform for family health and disease management. It provides health records’ access, information sharing with professionals, treatment planning and monitoring, emergency support, with a focus on patient consent and privacy, and alerting of any abnormal situation as it is defined by health care professionals, using international and open interoperability standards. 

Therefore, eHealthPassTM platform can move freely between the member states. As such, CE Marking can be seen as “passport” for the European marketplace. This is also an identifier that our platform has a high level of health, safety and environmental protection, as it meets the requirements of the European Directives. Our company complies with the requirements of the directives and has taken account of the current state-of-the-art procedures. Users of CE marked eHealthPassTM platform enjoy the same level of protection.