The Legislation for Medical Devices in Norway

1. Legal Basis and Implementation

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 primary national legislation is the Medical Devices Act and associated regulations. 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/the-legislation-for-medical-devices

2. Key Regulations

• Regulation (EU) 2017/745 on medical devices (MDR)
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
• Norwegian Medical Devices Act (Lov om medisinsk utstyr)
• Regulations on medical devices (Forskrift om medisinsk utstyr)
• Implementing acts and delegated acts from the European Commission National provisions supplement EU regulations where required for national enforcement. https://www.dmp.no/en/medical-devices/guidance-and-regulations/the-legislation-for-medical-devices

3. Competent Authority Role

NoMA acts as the designated competent authority under MDR/IVDR. Responsibilities include market surveillance, vigilance coordination, designation of notified bodies (where applicable), guidance issuance, and administrative enforcement. NoMA cooperates with other EEA authorities and the European Commission. https://www.dmp.no/en/medical-devices/guidance-and-regulations/the-legislation-for-medical-devices

4. Transitional Arrangements

Legacy devices certified under the previous directives (MDD 93/42/EEC, AIMDD 90/385/EEC, IVDD 98/79/EC) may continue to be placed on the market during transitional periods specified in MDR/IVDR Article 120 and related provisions. NoMA provides specific guidance on application of transitional rules in Norway. https://www.dmp.no/en/medical-devices/guidance-and-regulations/the-legislation-for-medical-devices

5. National Adaptations and Supplements

Certain provisions require national implementation, such as language requirements, vigilance reporting routes, and penalties for non-compliance. The Medical Devices Act and regulations establish national penalties and enforcement mechanisms aligned with EU requirements. https://www.dmp.no/en/medical-devices/guidance-and-regulations/the-legislation-for-medical-devices

6. Related Legislation

• Regulation on clinical investigations and performance studies
• Regulation on vigilance and market surveillance
• Provisions related to economic operators, registration in EUDAMED, and UDI requirements NoMA maintains an overview of applicable legislation and issues updated guidance as new delegated/implementing acts are adopted. https://www.dmp.no/en/medical-devices/guidance-and-regulations/the-legislation-for-medical-devices