Transitional Provisions for Medical Devices in Norway

1. Legal Basis

The transitional provisions are set out in Article 120 of Regulation (EU) 2017/745 (MDR). These provisions allow certain legacy devices to continue to be placed on the market under specific conditions during the transition from the previous directives (MDD 93/42/EEC and AIMDD 90/385/EEC) to the MDR. Norway applies these provisions directly through the EEA Agreement. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

2. Applicability to Legacy Devices

Legacy devices are those lawfully placed on the market under the MDD or AIMDD before 26 May 2021 and which continue to be placed on the market after that date under the transitional provisions. The provisions apply to devices with valid certificates issued under the previous directives. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

3. Key Deadlines

• Devices with certificates issued before 26 May 2021 may continue to be placed on the market until the certificate expires or until 27 May 2025 (for class I self-certified devices) or later dates depending on risk class and certificate validity.
• Certificates issued after 26 May 2021 but before the full application of MDR (under certain conditions) have specific expiry rules.
• No extension beyond 27 May 2025 for most class I self-certified devices unless specific conditions are met. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

4. Conditions for Continued Placement

• The device must continue to comply with either the MDD/AIMDD or the MDR (manufacturer's choice).
• No significant changes to the design or intended purpose that would require a new conformity assessment under MDR.
• Continued compliance with post-market surveillance, vigilance, and registration obligations under the applicable directive or MDR.
• For higher-risk devices, involvement of a notified body may still be required under transitional rules. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

5. Post-Market Surveillance and Vigilance

Manufacturers must maintain post-market surveillance and report serious incidents and field safety corrective actions in accordance with the requirements of the directive under which the device was certified or the MDR (whichever is stricter). Reports are submitted to NoMA as the national competent authority. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

6. NoMA's Role and Guidance

NoMA monitors compliance with transitional provisions, provides national guidance on their application in Norway, and may conduct market surveillance activities on legacy devices. Manufacturers should consult NoMA guidance for specific scenarios, including significant changes and expiry of transitional periods. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices

7. Practical Implications

During the transitional period, economic operators must ensure traceability and provide appropriate information to users. After the transitional deadlines, all devices must fully comply with MDR requirements, including CE marking under MDR and registration in EUDAMED. https://www.dmp.no/en/medical-devices/guidance-and-regulations/transitional-provisions-for-medical-devices