CE Marking of Conformity for Medical Devices and IVDs in Norway

1. Definition and Purpose

The CE marking is the visible symbol that the manufacturer has ensured that the device complies with all applicable requirements of the MDR or IVDR. It indicates that the device may be placed on the market throughout the EEA, including Norway. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

2. Legal Basis

The CE marking is regulated under MDR Article 20 and IVDR Article 18. Norway applies these EU regulations directly through the EEA Agreement. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

3. When CE Marking Is Required

CE marking is mandatory for all medical devices and IVDs placed on the market in Norway, except custom-made devices (which require a statement instead) and devices for clinical investigation or performance study. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

4. Affixing the CE Marking

The CE marking must be affixed visibly, legibly and indelibly to the device, its packaging and the instructions for use. It must be at least 5 mm high (unless the device is too small). The identification number of the notified body (if involved) must accompany the CE marking when the conformity assessment procedure requires notified body involvement. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

5. Manufacturer Responsibilities

The manufacturer is solely responsible for affixing the CE marking after completing the applicable conformity assessment procedure and drawing up the EU declaration of conformity. The CE marking must not be affixed before all requirements are met. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

6. Notified Body Identification Number

When a notified body is involved in the conformity assessment (e.g., for Class IIa, IIb, III devices or higher-risk IVDs), its four-digit identification number must be placed immediately after the CE marking. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity

7. Practical Considerations

The CE marking enables free movement of compliant devices across the EEA. Incorrect or premature affixing can lead to enforcement actions by NoMA. Manufacturers should consult the Blue Guide and MDCG documents for detailed guidance on placement and format. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/ce-marking-of-conformity