What is a CE Mark?
A CE Mark is a symbol applied to products to indicate to its users that it conforms with relevant EU directives regarding quality, health and safety or environmental protection.
You can read more about Medical devices: conformity assessment and the CE mark on the gov.uk website.
Why would a CE Mark be relevant to ConsentWise?
Patients and healthcare providers increasingly use medical apps (also known as web applications or simply software). Some medical apps are considered as medical devices. ConsentWise is classed as medical software. This is an umbrella term for software dedicated to improving the healthcare delivery process. Some examples of well-known medical software are:
- Clinic Information System (CIS)
- Electronic Prescription (EP) System
- Clinical Decision Support Systems (CDSS)
Medical software can be classified as either embedded or standalone. Embedded software is commonly integrated into medical devices such as a heart rate monitor. Standalone software is not integrated into a device, but could potentially influence the use of other devices or could be used to make a clinical decision.
Does ConsentWise require a CE Mark?
No. ConsentWise does not require a CE Mark.
Why not?
The ConsentWise software is standalone, not embedded. Our software is dedicated to performing actions that improve workflow and efficiency for healthcare teams (through our unique approach to data & file storage combined with search and communication tools). It does not influence clinical decision making. It is outwith the scope of medical devices regulation and therefore CE marking is not necessary.
