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February 15, 2026
Approximately 5 minutes
Classification of Medical Devices and IVDs in Norway
1. Legal Basis
Classification follows Annex VIII of Regulation (EU) 2017/745 (MDR) for medical devices and Annex VIII of Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices. Norway implements these EU regulations directly via the EEA Agreement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
2. MDR Classification Rules
Medical devices are divided into four risk classes: Class I (lowest), IIa, IIb and III (highest). Classification is determined by 22 rules in Annex VIII covering:
- Non-invasive devices
- Invasive devices (through body orifices or surgically)
- Active devices
- Special rules for devices incorporating medicinal substances, animal tissues, or absorbed by the body https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
3. IVDR Classification Rules
IVDs are classified into four risk classes: A (lowest), B, C and D (highest). The 7 rules in Annex VIII consider intended use, risk to individual patient and public health, with examples including:
- Class D: high public health risk (e.g., HIV, HBV, blood grouping)
- Class C: high individual patient risk or moderate public health risk
- Class B: moderate individual risk
- Class A: low individual and public health risk (e.g., general laboratory reagents) https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
4. Manufacturer Responsibility
The manufacturer must correctly classify the device and justify the decision in the technical documentation. Classification affects the conformity assessment route and notified body involvement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
5. Notified Body Role
Notified bodies verify classification during conformity assessment for Class IIa, IIb and III devices (and certain Class I sterile/measuring devices). Self-certification applies to most Class I devices. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
6. NoMA Guidance and Advice
The Norwegian Medicines Agency (NoMA) issues national guidance on classification rules and may provide non-binding classification opinions on request. Manufacturers are encouraged to consult MDCG guidance documents for consistent EEA-wide interpretation. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
7. Practical Implications
Correct classification determines:
- Conformity assessment procedure
- CE marking requirements
- Post-market surveillance obligations
- Vigilance reporting Misclassification can result in enforcement actions by NoMA. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
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