Learn about the interoperability and security standard for digital medical devices

Prerequisites

The solution must have earned CE marking.

01. Identify the core documentation that is relevant to you

Start-up

ANS

Learn about the security and interoperability standard

Download the standard

02. Upgrade your solution

Bring your solution into compliance with the standard

Matter of note: Updating your digital device may have an impact on your CE marking.

Need help?

If you're having any difficulties with your solution's compliance with the security and interoperability standard, you can direct your questions to your notified body.

Download the entire step-by-step guide as well as the checklist summarising all the actions to be taken

Mon parcours guidé remboursement de ma solution de télésurveillance