Free Sales Certificates for Medical Devices and IVDs in Norway

1. Purpose and Scope

The Norwegian Medical Products Agency (NoMA) may, upon request, issue time-limited Free Sales Certificates to Norwegian manufacturers or authorised representatives. These certificates confirm that the medical device or IVD complies with applicable EU regulations (MDR/IVDR or old directives) and is registered in Norway’s national database. They are typically required by export markets to prove regulatory compliance and market authorisation in the country of origin. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

2. Applicable Regulations

Certificates are issued under the current MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746), as well as legacy MDD (93/42/EEC) and IVDD (98/79/EC) where relevant during transition periods. Norway applies these EU rules directly through the EEA Agreement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

3. Application Process

Download and complete the appropriate Word template:

• For MDR/IVDR devices
• For MDD/IVDD devices

Required attachments:

• Completed template
• EU Declaration of Conformity
• Copy of “Utstyrsrapport” from the Norwegian Device Register confirming national registration

For devices requiring notified body involvement, include a copy of the notified body certificate. Up to 10 copies of the certificate may be requested. All devices listed on the certificate must be covered by the submitted documentation. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

4. Submission and Timeline

Submit the completed template, attachments and request to msod@noma.no. Normally a certificate is issued within one month. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

5. Manufacturer/Authorised Representative Responsibilities

The applicant must ensure all information is accurate and covers every device listed. The certificate is time-limited and does not replace full conformity assessment or CE marking obligations. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

6. Contact Information

For questions or support, contact NoMA’s Unit for medical devices – market surveillance at (+47) 22 89 77 00 or msod@noma.no. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate

7. Practical Notes

Certificates are not issued on a general basis or for unlimited periods. They are strictly for export purposes and must reflect current regulatory status. Always verify requirements of the target export country before applying. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/free-sales-certificate