Start with Device Classification

Determine your device class in minutes

Why Classification Matters

Classifying your medical device is a crucial first step in complying with EU regulations. Under the Medical Device Regulation (MDR, EU 2017/745), devices are divided into four risk-based classes (I, IIa, IIb, III), and this classification essentially defines the regulatory pathway for your product.
Knowing your device's class tells you how much oversight is needed and what requirements apply – including whether you'll need a Notified Body (an independent reviewer) to certify your device. Getting the classification right ensures you're following the correct process to achieve CE marking – the certification you must have to legally market your device in Europe.

How Our Tool Helps

Our tool simplifies this process by translating the MDR's official classification rules into an easy step-by-step questionnaire. You don't need to wade through legal jargon – just answer a few straightforward questions about your device's intended use, duration of contact with the body, and other key factors.
Based on your answers, the system will determine your device's class according to the MDR Annex VIII criteria. Each step includes helpful hints and plain-language definitions, so the process stays simple and guided from start to finish.
1
Basic Info
2
Usage
3
Composition
4
Risk
5
Review

Next Steps After Classification

Once you know your classification, you're ready for the next steps in your certification journey. Your device's class will inform what comes next – whether it means preparing detailed technical documentation or involving a Notified Body for final approval.
With this knowledge in hand (and our platform's guidance), you can proceed confidently through the rest of the step-by-step tool, knowing you're on the right track toward CE certification and compliance.

Did You Know?

  • Every medical device needs a CE marking to be sold in the EU, and proper classification is the first step to getting it.
  • Classification determines how much regulatory oversight your product needs, how long it might take to reach the market, and what kind of evidence you must provide.
  • Misclassification isn't just a minor mistake – it can lead to expensive delays, rejected applications, product recalls, or even legal consequences.