FAQ
The CE marking is like a passport to sell your medical software in Europe. It shows that your product complies with all the safety and performance requirements set by the European regulations (MDR 2017/745).
Without this marking, you cannot place your software on the European market, which significantly limits your business opportunities.
We simplify the process of obtaining the CE marking by guiding you through each step with clarity and confidence. You have exciting projects to work on, so why not let us handle the regulatory aspects, allowing you to focus fully on the innovation and development of your software?
If your software is intended to be used for medical purposes (diagnosing, treating, monitoring), it is most likely a medical device and must bear the CE marking.
Understanding whether your software is a medical device is the first crucial step. This will define all the legal and regulatory obligations you need to comply with to market your product. A mistake at this stage could lead to legal complications or delays in bringing your product to market.
We help you define a clear regulatory strategy tailored to your software. We assist you in evaluating the classification of your software based on its usage and associated risks, and then we work together to establish the procedure to follow (self-certification or involvement of a notified body). Our goal is to ensure that you feel comfortable and confident at each phase, while supporting you in preparing the necessary documents for successful certification.
Medical software is classified into four categories: I, IIa, IIb, and III.
- Class I: Low risk. The CE marking process for Class I software is the simplest – self-certification (no need for a notified body).
- Class IIa, IIb, III: Medium to high risk. For these, you must work with a notified body, an independent organization that will verify if your software meets the requirements.
The classification of your software determines the procedure and the requirements you must comply with. The higher the risk class, the more rigorous and complex the process becomes.
This will directly influence the duration of the process and the resources required to obtain the CE marking.
A notified body is a certification organization authorized by the European authorities to verify that medical devices (and therefore your software) meet safety and performance standards (e.g., BSI, GMED, AFNOR, etc…).
If your software is classified as Class IIa, IIb, or III, you must go through a notified body to obtain the CE marking.
This depends on the class of your software and the preparation of your documentation. In general, it can take between 6 months, 1 year or even up to 2 years. The more complex your software is, and the higher the risk class, the longer the process will take.
Timing is crucial for planning the launch of your product. This estimate allows you to allocate resources and time accordingly. It is essential to manage this step correctly to avoid delays in bringing your product to market.
We ensure that all steps are completed within the required timeframe, so you can confidently plan your market launch.
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