What is CE Marking?

A CE mark is a logo that is placed on medical devices to show they reach required medical standards. It shows that the device is fit for its stated intended purpose and meets legal safety standards. It shows the product can be freely marketed anywhere in the European Union. You can find out more about CE marking on medical devices on this Government Medical devices page.

Why do I see CE Marking within the ‘Health Advice’ feature in Patient Access?

EMIS Health was required to register with the Medicines & Healthcare products Regulatory Agency (MHRA) as a manufacturer of medical devices. For any new development on the Patient Access app, Patient Limited and EMIS Health must consider if the way it is designed to be used means it qualifies as Software as a Medical Device (SaaMD).

The ‘Health Advice’ feature within the Patient Access app has forms that have been created and peer reviewed by GPs and those with the CE Marking have been identified as qualifying as SaaMD. CE marked Health Advice forms are specific to you as an individual patient.

We have CE marked the patient forms which are authored and peer reviewed by our GPs. These forms contain algorithms which direct patients to different outcomes based on their symptoms and responses to questions.

We have not CE marked links to information or signposting, as this is no different to information already available on https://patient.info.

Practices can also create their own forms. These have not been authored or peer reviewed by our GPs, so we cannot guarantee that they meet the specific standards for CE marking. This means that these forms are not CE marked.

What qualifies as a Medical Device?

• Data alone is not a medical device – only when it becomes software.
• The software or app feature must have a medical purpose to qualify as a medical device.
• It must be specific to individual patients (patient-specific score / alert) and/or
• It must have a clinical purpose (diagnosis, treatment) and/or
• It must have an expert function (calculator, algorithm).