New process for handling medical devices within the Norwegian “New Methods” framework

On May 1, 2026, the new process for handling medical devices within the “New Methods” framework came into force. Under this framework, four Regional Health Authorities jointly decide whether new treatment methods should be covered in specialist health services. The framework applies to medical devices, in vitro diagnostic devices, and AI ​​systems that qualify as medical devices.

Responsibilities within the framework are divided as follows: the Norwegian Medical Products Agency (NOMA) conducts feasibility assessments and health technology assessments (HTAs); the Ordering Forum (Bestillerforum) decides whether a national HTA should be conducted and what type is required; the Hospital Procurement Authority (Sykehusinnkjøp HF) handles procurement and price negotiations; and the Decision Forum (Beslutningsforum) decides whether the method should be introduced into specialist healthcare services.

The key changes concern the implementation of new entry pathways into the framework and the establishment of clear selection criteria.

Three entry pathways are now available:

• Joint European HTA (HTAR). EU-level Joint Clinical Assessments (JCAs) for medical devices have been applied since January 2026. Norway is currently clarifying how these assessments will be integrated into “New Methods”. HTAR applies to Class III devices, certain Class IIb devices, and Class D IVDs, meeting criteria such as addressing unmet medical needs, being first-in-class, incorporating AI/machine learning, or having a significant impact across the EEA.
• Requests from manufacturers and proposals from other stakeholders. Manufacturers may submit requests for assessment using a dedicated submission form that incorporates the selection criteria. Other stakeholders, including healthcare professionals, may also propose devices for assessment (separate submission form).
• Input from regional procurement bodies and the Hospital Procurement Authority. Procurement bodies within the health regions will play a more active role in identifying and proposing devices for assessment based on clinical and procurement needs.

The new selection criteria clarify which devices must be considered within the framework. The criteria are grouped into four categories (A–D). A device must be proposed if all criteria in categories A, B, and C are met, together with at least one criterion in category D. Although devices that do not meet the criteria may still be proposed and assessed.

• A – Is the device within the funding responsibility of the specialist health service? The Regional Health Authorities are financially responsible for the medical device when the initiation, evaluation, and discontinuation of the treatment are managed by specialist healthcare physicians.
• B – CE-marking: The device must be CE marked to be assessed in the framework
• C – Whether the device provides added value in patient outcomes compared with existing treatment or diagnostic methods in Norway.
• D – Other aspects. Costs: whether implementation is expected to generate significant costs for specialist healthcare services; an estimated budget impact above NOK 50 million within three years. Healthcare personnel impact: whether the device may significantly affect healthcare staffing, workload, or task shifting. Organizational impact: whether the device may lead to major organizational changes within healthcare services.

See the full details in Norwegian here.

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