Qualification of Products as Medical Devices in Norway

1. Qualification Process Overview

Qualification is the first step to determine whether a product falls within the scope of medical device regulations. It is based on the definitions in Article 2 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Norway applies these EU definitions directly through the EEA Agreement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

2. Definition of Medical Devices

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

3. Definition of IVD Medical Devices

An in vitro diagnostic medical device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for providing information on physiological or pathological processes, congenital impairments, predisposition to medical conditions or diseases, safety and compatibility with potential recipients, prediction of treatment response or reactions, or defining or monitoring therapeutic measures. Specimen receptacles are also deemed to be in vitro diagnostic medical devices. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

4. Intended Purpose

Intended purpose is defined as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation/performance evaluation. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

5. Borderline Products and Accessories

Borderline products between different regulatory frameworks (e.g., medical device vs. medicinal product, cosmetic, biocide) require case-by-case assessment based on intended purpose, mode of action, and claims. Accessories for medical devices/IVDs are also covered if intended to enable or assist the medical device. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

6. Products Without Intended Medical Purpose

Certain products listed in MDR Annex XVI (e.g., contact lenses, dermal fillers, liposuction devices, high-intensity electromagnetic radiation devices, brain stimulation devices) are regulated as medical devices even without a medical intended purpose due to function and risk profile. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

7. EU MDCG Guidance

NoMA refers to MDCG guidance documents for consistent qualification and classification, including MDCG 2021-24 (borderline between medical devices and medicinal products), MDCG 2020-16 (classification rules), MDCG 2019-11 (software qualification), and MDCG 2024-11 (IVD qualification). https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

8. Manufacturer Responsibility and NoMA Advice

Manufacturers are responsible for correct qualification. Documentation of the decision and rationale must be kept in the technical file. Manufacturers may request non-binding advisory opinions from NoMA for uncertain cases by submitting detailed product information. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification

9. Consequences of Qualification

Correct qualification ensures compliance with applicable regulations (MDR/IVDR for medical devices, or alternative frameworks otherwise). Incorrect qualification may lead to enforcement actions by NoMA, including market restrictions. https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification/qualification