Borderline products

Guidance on classification

If it is unclear which risk class the device belongs to, we recommend consulting the EU guidance for the classification of medical devices (MDCG 2021-24) or the EU guidance for the classification of IVD devices (MDCG 2020-16) to check if similar devices are listed there.
Links to the classification guidances can be found on the webpage on classification of medical devices.

A manual for borderline products and classification under MDR and IVDR has been published. A corresponding manual exists for the older directives (MDD/AIMDD/IVDD). This manual is no longer updated but has been retained for reference and use as long as devices with CE-marking issued under the directives remain available on the market. The manual for MDR/IVDR is updated continuously.

Links to the manuals and other relevant guidance documents can be found in the overview of useful links at the bottom of the page.

Discussion of classification issues

Helsinki Procedure

European competent authorities may discuss issues concerning the qualification and classification of medical devices. Such discussions are conducted in accordance with a specific procedure referred to as the Helsinki Procedure. Decisions on qualification and classification matters that have been considered under the Helsinki Procedure and for which a sufficient level of consensus has been achieved among the authorities are summarized in the Manual on Borderline and Classification for the former directives (MDD/AIMDD/IVDD) and the current regulations (MDR/IVDR), respectively. While these decisions are not legally binding, they may be used as guidance.

Disagreement on classification

If a manufacturer and a notified body disagree on the classification of a device, the matter must be decided by the competent authority in the Member State where the manufacturer is established. In Norway, the competent authority is the Norwegian Medical Products Agency (NOMA).

If the notified body is established in a Member State other than that of the manufacturer, the competent authority in the Member State where the notified body is established must also be involved before a decision on classification can be made.

Related product categories and regulatory guidance

Classification under other regulatory frameworks

If you would like to have your product classified under another regulatory framework, or if you need guidance on the classification requirements for different product categories, please contact the authority responsible for the relevant legislation under which you intend to market your product:

• Cosmetics, food and food supplements: Norwegian Food Safety Authority 
• Biocidal products: Norwegian Environment Agency
• Personal protective equipment (PPE): Norwegian Directorate for Civil Protection 

Do you believe your product may be a medical device and would like further guidance?

Please contact us at kki@noma.no. When contacting us, describe the product in as much detail as possible and include its intended purpose and proposed risk class, together with the rationale for the proposed classification.

Please note that it is the manufacturer's responsibility to classify its own product and ensure compliance with the applicable legislation. The role of NOMA is to provide guidance.

Do you believe your product may be a medicinal product and would like further guidance?

Please contact us at classification@noma.no. You can also find guidance on our webpage on classification of medicinal products.

See also MDCG 2022-5 for guidance on borderline issues between medical devices and medicinal products (see the overview of useful links at the bottom of this page).

Tooth whitening products

Tooth whitening is not considered to have a medical purpose, but is regarded as an aesthetic/cosmetic treatment. This issue has been discussed by European competent authorities for medical devices. The conclusion is published in the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, section 6.1: “Tooth whitening/bleaching products whether placed within the tooth cavity or placed on the surface of the teeth should not be qualified as medical devices”.

Accordingly, tooth whitening products are not covered by the medical devices legislation. It is therefore not permitted to market tooth whitening products as medical devices.

The decision from September 2016, in which Norwegian authorities required the withdrawal of tooth whitening products CE-marked as medical devices from the Norwegian market, remains in force.

For further information, please refer to the Norwegian Food Safety Authority’s website on tooth whitening (in Norwegian).