Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Evidence requirements for medical devices in the “New methods” framework in Norway
Get insights from MTRC White Papers to explore the evidence requirements related to the 'New Methods' framework from the 5 recent med tech assessments in Norway.
Recent news and posts
New process for handling medical technologies within the “New Methods” framework in Norway
The Norwegian “New Methods” framework is the national system for introducing new health technologies, requiring innovations to undergo health technology assessment (HTA) prior to funding decisions. Since 2021, efforts have been underway to update processes for non-pharmaceutical medical technologies, i.e., medical devices, in-vitro diagnostics, procedures, and organizational measures.
In late March 2026, it was announced that a new process for medical technologies would take effect on May 1, 2026. As part of the rollout, medical device suppliers are invited to attend a digital information meeting on April 17, 2026. The session will present the updated process, including submission requirements and application forms, and will provide an opportunity for questions. The registration deadline is April 14, 2026.
The updated process introduces several key elements.
First, it revises how medical devices are identified and submitted to the framework through three entry pathways:
- EU-level health technology assessments (Joint Clinical Assessments, JCA);
- Requests for evaluation submitted by suppliers or proposals from stakeholders such as clinicians;
- Input from regional procurement bodies and the Hospital Procurement Authority (Sykehusinnkjøp HF).
Second, the framework introduces revised selection criteria to determine which medical devices will undergo HTA.
Third, an early assessment step will be implemented for submitted requests and proposals to streamline decision-making.
Additionally, procurement processes for devices requiring HTA will be postponed and better aligned with assessment timelines.
Finally, an implementation meeting will be introduced to support the adoption of approved technologies.
Further details on the updated process are expected to be published by the “New Methods” framework in the near future.
See the full details hereand 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.