🇳🇴 Norway IVD regulatory data

Submission Surface

EUDAMED

Details

Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.

The current DMP guidance requires economic-operator and device registration in EUDAMED. For the same legal person, changes to the registered actor information must be updated within one week under MDR 31(4) or IVDR 28(4). A Local Actor Administrator creates and registers a new actor-data version. Tax/trade-ID changes use a distinct authority-validated request; pending such a request blocks other actor-detail changes. These technical edits do not establish transfer of a manufacturer to another legal person.

MDCG 2022-6 distinguishes administrative manufacturer name/address/legal-form changes, including its merger/acquisition example, from significant design/intended-purpose changes for legacy IVDs. This design-change guidance does not itself establish a transfer of conformity responsibility or a universal certificate-succession procedure. Observe the actual certificate conditions and agreed notified-body change procedure; current transition dates must come from amended law, not the old dates printed in this 2022 guide.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.

The current DMP guidance requires economic-operator and device registration in EUDAMED. For the same legal person, changes to the registered actor information must be updated within one week under MDR 31(4) or IVDR 28(4). A Local Actor Administrator creates and registers a new actor-data version. Tax/trade-ID changes use a distinct authority-validated request; pending such a request blocks other actor-detail changes. These technical edits do not establish transfer of a manufacturer to another legal person.

MDCG 2022-6 distinguishes administrative manufacturer name/address/legal-form changes, including its merger/acquisition example, from significant design/intended-purpose changes for legacy IVDs. This design-change guidance does not itself establish a transfer of conformity responsibility or a universal certificate-succession procedure. Observe the actual certificate conditions and agreed notified-body change procedure; current transition dates must come from amended law, not the old dates printed in this 2022 guide.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.

Submission Surface

EUDAMED

Details

Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

MDCG 2022-6 distinguishes administrative manufacturer name/address/legal-form changes, including its merger/acquisition example, from significant design/intended-purpose changes for legacy IVDs. This design-change guidance does not itself establish a transfer of conformity responsibility or a universal certificate-succession procedure. Observe the actual certificate conditions and agreed notified-body change procedure; current transition dates must come from amended law, not the old dates printed in this 2022 guide.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.

Submission Surface

EUDAMED

Details

Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.

Under the corresponding MDR/IVDR rules implemented in Norway, a new UDI-DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade-name or version/model change. An actual catalogue/REF change is not automatically the same thing: assess its effect on identity and traceability. A change to an existing UDI database element that does not require a new UDI-DI must be updated within 30 days. Cosmetic artwork alone is not listed as an automatic new-UDI trigger.

A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its name or trademark; that manufacturer must meet the applicable manufacturer duties. A true change to that legal person is not established by editing the old actor name, by a local importer change or by an AR handover alone. Establish the new responsible manufacturer’s conformity evidence, registration, UDI/device data and representative mandate before its affected devices are placed on the market. For an AR-only change, Article 12 requires an agreement covering mandate dates, outgoing-representative indication, document transfer and complaint forwarding.

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

DMP issues FSCs to Norwegian manufacturers and authorised representatives for relevant exports outside the EU/EEA. Use the MDR/IVDR template for current-law devices and the directives template for qualifying legacy devices. Provide the correctly completed identity/product data, requested copies (maximum 10), declaration of conformity and applicable notified-body evidence covering every listed product; the stated MD and IVD class branches require a certificate copy. Legacy applications also need the stated notified-body confirmation. The published normal issue period is one month, not an ordinary change-review SLA.

Under the corresponding MDR/IVDR rules implemented in Norway, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device-range changes; it assesses the proposal and any necessary audits. Under Annex IX 4.11, a change to an approved device that could affect safety, performance or prescribed conditions of use needs the issuing body’s approval. The body decides whether a new conformity assessment or a certificate supplement is required. An identity-data edit does not settle that decision.

Under the corresponding MDR/IVDR rules implemented in Norway, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered-place-of-business address, plus the representative where required and the applicable UDI carrier. Keep the actual post-change device/manufacturer identities consistent with the conformity and registration records. This label-content rule is not an old-stock grace or a permission to use another company’s certificate.

Qualifying devices lawfully placed on the market under the former rules or the applicable transition may continue to be made available or put into service under the stated provisions. This is a lawful-placement condition for the actual units; it does not authorise newly changed or non-conforming devices, or automatically extend an old manufacturer/brand label after a transfer. Establish placement date, conformity/legacy status, batch identity and whether the proposed alteration changes that basis.