Log into the Register for Medical devices
Norwegian manufacturers and authorised representatives, and any physical or legal person who assembles the medical devices provided with a CE mark (further information under placing on the marked of medical devices), are obliged to register their Medical device in the Norwegian Register for Medical devices.
Registration should be performed at the start time of the placing on the marked of the medical device, and includes registration of which device in question, manufacturer name, organization number, and business address (for full list see "First Registration" link). The person responsible for the registration is also responsible for ensuring that the information in the Register for Medical devices is always kept up to date.
Registration of a medical device in Register for Medical devices does not imply that the Norwegian Medicines Agency as a national competent authority for medical devices, has taken a position on whether the medical device falls under the definition of medical devices, referring to the Act of 12 January no 6 on medical devices § 3, or if the classification is correct.
To register in the Register for Medical devices must the subject obliged to register submit the information requested below. The subject obliged to register will then receive a username and password by e-mail.
NB! Before first registration read thoroughly the Guideline for the obligation to register cf. Regulation on medical devices § 2-8 by the Norwegian Directorate of Health and the Directorate for Civil Protection (link Guideline for the obligation to register).
The following information is sent to email@example.com
- Name of the manufacturer
- Organization no
- Visit adress
- Post adress
- Contact person
- Contact person phone
- Type of device (medical device or in vitro diagnostic medical device)
- A copy of the Declaration of conformity of the medical device (does not apply to custom- made medical devices)
- Type of business (manufacturer, authorised representative)
- Website (if this exist)
About the obligation to register
The obligation to register in the Register for Medical devices is described in: