Proposed updates in New Methods framework processes related to medical devices in Norway

In April 2025, the Regional Health Authorities, in collaboration with the Norwegian Directorate of Medical Products (NOMA) and the Hospital Procurement Authority (Sykehusinnkjøp HF), published proposals to improve the New Methods framework processes. The proposed changes aim to strengthen the prioritization, assessment, and implementation of medical devices in the specialist health service. The proposals are open for public comment until May 18, 2025.

Three pathways are proposed for medical devices to enter the New Methods framework:

• Through the European Joint Clinical Assessment under the HTAR framework. Assessments of medical devices are expected to begin in January 2026;
• Applications submitted by suppliers of medical devices, as well as by clinical or other relevant stakeholders;
• Input from regional procurement bodies and the Hospital Procurement Authority.

Revised selection criteria, forming part of the application for assessment of medical devices within the New Methods framework, have also been proposed. These criteria are divided into four categories (A–D):

A – Is the technology within the funding responsibility of the specialist health service?

B – Is the technology CE-marked?

C – Does the technology provide additional benefits, address an unmet need, or relate to existing substitute methods?

D – Other aspects. The applicant must indicate ‘yes’ or ‘no’ for each of the following five points, provide justification, and complete all sections of the form. Questions are concerning patient group, budgetary impact/costs, organisational consequences, impact on health personnel resources, and device risk classification.

If the criteria in categories A, B, and C, along with one or more criteria in category D, are answered ‘yes’, the technology must be proposed for assessment under the New Methods framework. The Ordering Forum will then decide whether a method assessment is to be carried out, and if so, what type of assessment.

The proposed changes also include earlier evaluation of submitted cases and improved coordination of procurement processes requiring method assessment. Additionally, a plan for ongoing evaluation has been introduced to ensure that the framework continues to meet the evolving needs of the specialist health service.

See the full details in Norwegian here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.