European Union · Medical Devices
EU MDR Classification
A practical guide to EU MDR Classification for medical devices sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Medical devices placed on the EU market
- Software and accessories qualifying as medical devices
Documents you need
- Technical file
- Clinical evaluation
- Quality management system documentation
- UDI information
Compliance checklist
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How to comply
- Classify the device under MDR rules
- Implement the quality management system
- Involve a notified body where required
- Apply CE marking and register in EUDAMED
Brief for your lab or agent
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Request: EU MDR Classification — European Union Product category: Medical Devices Authority: Notified bodies and national competent authorities Legal basis: Regulation (EU) 2017/745 (MDR) Documents we already have: 1. Technical file 2. Clinical evaluation 3. Quality management system documentation 4. UDI information Questions: 1. Does our product fall under EU MDR Classification in the European Union? 2. Which test standards or evidence do you accept? 3. What is the current fee and lead time? 4. Is a local representative required, and can you act as one?
Cost and timeline
Before market placement; depends on the conformity assessment route.
Notified body and assessment fees vary widely.
Common rejection reasons
- Device misclassified
- Clinical evaluation insufficient
- Notified body involvement missing where required
Official sources
FAQ
How are devices classified?
MDR uses classes I, IIa, IIb, and III based on risk, with separate rules for certain devices.
When is a notified body required?
Generally for class IIa and higher, and for certain class I devices.
What is UDI?
The Unique Device Identification system identifies devices through distribution and is linked to EUDAMED.
How long does EU MDR Classification take?
Before market placement; depends on the conformity assessment route.
How much does EU MDR Classification cost?
Notified body and assessment fees vary widely.
What happens if I sell without it?
Withdrawal, recall, and enforcement action.
Who regulates EU MDR Classification in the European Union?
Notified bodies and national competent authorities.
Related requirements
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