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February 17, 2026
Approximately 5 minutes
Classification Rules for Medical Devices and IVDs in Norway
Classification Rules for Medical Devices and IVDs in Norway
1. Legal Basis
Classification of medical devices follows Annex VIII of Regulation (EU) 2017/745 (MDR). In vitro diagnostic medical devices follow Annex VIII of Regulation (EU) 2017/746 (IVDR). Norway implements these EU regulations directly through 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, and 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: Class A (lowest), B, C and D (highest). The 7 rules in Annex VIII consider intended use and the risk to the individual patient and public health. Examples include Class D for high public health risk (e.g., HIV, HBV, blood grouping) and Class A for low 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 is solely responsible for correctly classifying the device based on its intended purpose and must justify the decision in the technical documentation. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/classification-of-medical-devices
5. Role of Notified Bodies
Notified bodies verify classification during conformity assessment for Class IIa, IIb and III devices (and certain Class I sterile/measuring devices). Most Class I devices are self-certified. 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 upon request. Manufacturers should refer to 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 the conformity assessment route, CE marking requirements, post-market surveillance obligations and vigilance reporting. Misclassification can lead to 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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