Guidance and Regulations for Medical Devices in Norway

1. Regulatory Framework

Norway implements the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) through the EEA Agreement. The regulations apply directly in Norway with national adaptations where necessary. The Norwegian Medicines Agency (NoMA) is the competent authority responsible for oversight, guidance, and enforcement. https://www.dmp.no/en/medical-devices/guidance-and-regulations

2. Classification and Conformity Assessment

Devices are classified into risk classes I, IIa, IIb, and III (MDR) or A, B, C, D (IVDR). Conformity assessment procedures depend on class, involving self-declaration for low-risk devices and involvement of notified bodies for higher-risk classes. NoMA provides guidance on classification rules and borderline products. https://www.dmp.no/en/medical-devices/guidance-and-regulations

3. Clinical Evaluation and Performance Evaluation

Manufacturers must conduct clinical evaluation (MDR) or performance evaluation (IVDR) demonstrating safety and performance. NoMA issues guidance on clinical evaluation reports, sufficient clinical evidence, and equivalence claims. For IVDs, performance studies follow specific requirements. https://www.dmp.no/en/medical-devices/guidance-and-regulations

4. Vigilance and Post-Market Surveillance

Manufacturers must establish a post-market surveillance system and report serious incidents and field safety corrective actions to NoMA. NoMA coordinates vigilance activities, issues field safety notices, and maintains a national vigilance database linked to EUDAMED. https://www.dmp.no/en/medical-devices/guidance-and-regulations

5. Market Surveillance and Inspections

NoMA conducts market surveillance, including inspections of manufacturers, importers, and distributors. Non-compliance may lead to administrative sanctions, product withdrawal, or criminal penalties. Guidance is available on surveillance procedures and risk-based inspections. https://www.dmp.no/en/medical-devices/guidance-and-regulations

6. EUDAMED and Registration

Norway participates in EUDAMED. Actors must register in the database, and devices require UDI assignment. NoMA provides guidance on EUDAMED obligations, actor registration, and device registration during transitional periods. https://www.dmp.no/en/medical-devices/guidance-and-regulations

7. Language and Labeling Requirements

Information supplied with devices must be in Norwegian or English, with priority for Norwegian for lay users. NoMA offers guidance on labeling, instructions for use, and language exemptions. https://www.dmp.no/en/medical-devices/guidance-and-regulations

8. Transitional Provisions

Transitional arrangements allow continued placement of devices certified under the old directives (MDD/AIMDD/IVDD) until expiry of certificates or specific deadlines, subject to MDR/IVDR requirements. NoMA provides detailed guidance on transitional periods and legacy devices. https://www.dmp.no/en/medical-devices/guidance-and-regulations

9. Additional Guidance Topics

NoMA publishes guidance on topics including custom-made devices, systems/procedure packs, economic operators' obligations, clinical investigations, performance studies, and borderlines with other product legislation. https://www.dmp.no/en/medical-devices/guidance-and-regulations