Medical Device and EU HTA Regulation - Norwegian perspective
09 Jul 2023

Norway has developed a national system with mini-HTA and national evaluations that include medical devices and diagnostics.

The system is governed by the 4 regional health companies with the responsibility of specialist care, which creates a strong link between the aim to evaluate and the consequent decision to implement and fund treatments.  Based on this, the focus is on the ability to use the process for priority setting in the decision about what to implement. Interested to learn more, here is a video.

In a report from 2022(1), the 4 regional health companies gives their perspective on the issues relating to the introduction of the Medical Device Regulation (MDR) (2), In Vitro Diagnostic Regulation (IVDR) (3) and the HTA Regulation (HTAR) (4).

The report addresses several important aspects:

  • The type of products that are to be included are described in §54 in the MDR(2) and products of class D in the IVDR(3).
  • Within these classes, the following criteria should be considered in the priority setting of which methods to evaluate (1):
    • Unmet clinical need
    • Technologies which are first in class.
    • Potential impact for patients, public health and healthcare systems
    • Products that utilize machine learning and artificial intelligence.
    • Significant cross-boarder characteristics
    • Significant value for the whole European region.

The implementation of this will require an update of the current criteria regarding inclusion in the different HTA-evaluation processes. A work package has been initiated to address this question.

In the report(1), an example of a digital health solution for patients with lung disease is considered as type of technology that may be relevant to for the new HTAR process (4).

If you are working with a new medical device or IVD product that will qualify for this new process, it is important to strategically start planning for this. We can support you in this process, contact us.

Tag: Eunethta, MDR, IVDR, Joint Clinical Assessment


1.            Sluttrapport: Kunnskapsgrunnlag om implementering av medisinsk teknisk utstyr og videre utvikling for medisinske teknologier i spesialisthelsetjenesten [Internet]. [cited 2023 May 15]. Available from: 

2.            REGULATION  (EU)  2017/  745  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL [Internet]. 2017 p. 175. Available from:

3.            Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) [Internet]. OJ L, 32017R0746 May 5, 2017. Available from:

4.            Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) [Internet]. OJ L Dec 15, 2021. Available from: