Vetted consultants
How we vet consultants
Only firms that pass our review are listed here.
- We assess regulatory experience, service scope, and professional credentials.
- Approved status may be revoked if standards are not maintained.
February 17, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
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
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
Related Articles
Approximately 5 minutes
Classification of Medical Devices and IVDs in Norway
Norway classifies medical devices per MDR Annex VIII into risk classes I–III based on intended purpose, invasiveness, duration and active nature; IVDs per IVDR Annex VIII into classes A–D; manufacturer responsibility with NoMA guidance and notified body verification for higher classes.
Approximately 5 minutes
Quality Management System and Risk Management for Medical Devices in Norway
Norway requires manufacturers to establish a quality management system (ISO 13485) and risk management system (ISO 14971) from the development phase to ensure compliance with MDR/IVDR, covering design, production, post-market surveillance, and benefit-risk evaluation.
Approximately 5 minutes
Standards and Common Specifications for Medical Devices in Norway
Norway relies on harmonised European standards (CEN/CENELEC) and European Pharmacopoeia monographs for presumption of conformity with MDR/IVDR essential requirements; manufacturers may use other solutions but must document full compliance; NoMA references MDCG guidance for standardisation.
Approximately 5 minutes
Language Requirements and Information Supplied with Medical Devices in Norway
Norway mandates Norwegian language for labelling and instructions for use on medical devices to ensure safe and correct use by professionals and lay users, allows electronic instructions for use under specific conditions, requires implant cards in Norwegian for implantable devices, and permits strict case-by-case exemptions via application to NoMA.
Approximately 5 minutes
Unique Device Identification (UDI) System for Medical Devices in Norway
The UDI system in Norway assigns a unique code (UDI-DI and UDI-PI) to medical devices to enhance traceability, simplify recalls, combat counterfeiting, and improve patient safety, as required under MDR/IVDR with direct EEA application.