Turkey medical device regulations

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

For company transfer/merger, update the authorised signatories and users defined in ÜTS so the company’s ÜTS activities can continue. Changes to responsible manager, company title and address update automatically in ÜTS when updated in ÇKYS. This local firm-data mechanism does not itself establish transfer of a foreign manufacturer’s conformity certificate or responsibilities.

A distributor, importer or other person making a device available under its own name, registered trade name or trademark assumes manufacturer obligations, except for the stated agreement where the original manufacturer remains identified on the label and responsible. Certificates concern a single manufacturer and identify its registered name/address; revised or reissued certificates identify the earlier certificate and changes. A takeover must therefore be assessed against the actual manufacturer and certificate holder, rather than treated as a simple account rename or automatic inheritance.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

The manufacturer, incoming authorised representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former representative in supplied information, transfer of documents including confidentiality/property rights, and forwarding of later complaints or suspected-incident reports. This handover concerns the authorised representative; it does not itself transfer the manufacturer’s legal responsibility or certificate.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.

Maintain/register the supporting documents and link the appropriate declaration before the device application. For an ordinary Art 40 application select one declaration of conformity and the associated devices; the limit is 500 device notifications, with the same GMDN for legacy devices and the same Basic UDI-DI for new-regime devices except the stated ITC exception. Sign electronically and pay the applicable application fee before authority-review status. A document application is limited to 5 notifications; payment-required document types enter review after signature and payment. These limits do not authorize arbitrary change bundling or one overall fee/clock.

For company transfer/merger, update the authorised signatories and users defined in ÜTS so the company’s ÜTS activities can continue. Changes to responsible manager, company title and address update automatically in ÜTS when updated in ÇKYS. This local firm-data mechanism does not itself establish transfer of a foreign manufacturer’s conformity certificate or responsibilities.

A distributor, importer or other person making a device available under its own name, registered trade name or trademark assumes manufacturer obligations, except for the stated agreement where the original manufacturer remains identified on the label and responsible. Certificates concern a single manufacturer and identify its registered name/address; revised or reissued certificates identify the earlier certificate and changes. A takeover must therefore be assessed against the actual manufacturer and certificate holder, rather than treated as a simple account rename or automatic inheritance.

The guide describes importer certificate/declaration authentication and Turkish translation procedures and a distinct authorised-representative mandate/EUDAMED actor-printout route. The mandate rule is not the same as certificate/declaration legalization. Articles 8,12,15 and 39(4) take effect only when the specified procedures become technically functional in a ÜTS release; other guide provisions take effect at publication. Select the operating document route and its physical-petition requirements accordingly.

A CFS application contains no more than 1000 devices. Do not mix MDR, IVDR and legacy-regime groups; MDR/IVDR products in one application share the same Basic UDI-DI. Different destination-specific certificates require separate applications; English copies and an additional Turkish copy attract separate charges. Only devices Registered at the issuance date are included, so complete the affected identity/registration work before relying on the resulting CFS particulars.

For the local-manufacturer CFS, the sequence is upload → electronic signature/send → authority assessment → if suitable, fee accrual/payment reference → institutional payment → issuance. Pay within 10 days or ÜTS cancels automatically. The optional 3-working-day pickup hold follows payment/issuance arrangements; it is not a CFS assessment SLA.

For MDR and IVDR records, enter version/model and reference/catalogue number exactly as declared in the linked documents or label. At least one of those two fields must be populated. If the same declared information serves as model in a document and REF on the label (or conversely), enter it in both fields. UDI-DI must not be entered as either model or reference/catalogue number. Multiple declared reference numbers are recorded as the guide specifies.

For an export CFS requested by a local manufacturer, use ÜTS’s CFS application and the sample Excel downloaded from that application. Populate device barcodes and English product names matching the registered Turkish names, upload the file and sign/send for authority assessment. Devices must be Registered; Rejected or System-has-individual-product statuses cause rejection. The current application workbook is required for that execution route.

A foreign manufacturer’s Türkiye-established EU authorised representative registered in the specified ÜTS activity category requests the export CFS by an EBS petition. Its product list is an applicant-prepared PDF containing device barcodes and English names matching ÜTS Turkish names. The authority assesses the application and provides fee instructions; after payment it issues only for devices still Registered at issuance.

TRY 201–335

Per application

The general 2026 fee is TRY 335; the tariff’s 40% domestic-product support column shows TRY 201 when eligible.

TRY 335

Per document

TRY 3,349

Per certificate

TRY 6,634

Per certificate

TRY 9,918

Per certificate

The manufacturer, incoming authorised representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former representative in supplied information, transfer of documents including confidentiality/property rights, and forwarding of later complaints or suspected-incident reports. This handover concerns the authorised representative; it does not itself transfer the manufacturer’s legal responsibility or certificate.

Labels identify the device name or trade name and the manufacturer’s name, registered trade name or trademark and registered business address; an authorised representative is identified where applicable. The EU declaration of conformity identifies the responsible manufacturer, device/product or trade name, identification permitting traceability, catalogue reference where relevant and Basic UDI-DI. After an identity change these documents must describe the same responsible person and device.

Under Annex IX the manufacturer informs its notified body of planned substantial changes to the approved QMS or device range. Changes to an approved device that may affect safety/performance or conditions of use require the technical-documentation certificate issuer’s approval; the body decides between a new conformity assessment and a certificate supplement. A same-entity office rename/address change is not automatically a factory, design or significant QMS change.

A change that could cause misidentification or ambiguity in traceability requires a new UDI-DI, in particular a change in device name/trade name or device version/model. A commercial order code must first be mapped to the actual label and declared device identity; it is not automatically a UDI-DI or a model.

The transitional provisions allow devices lawfully placed on the market under the applicable legacy provisions to continue being made available or put into service. Further legacy placing remains subject to the relevant class/date, valid-certificate, QMS and application conditions and absence of significant changes in design or intended purpose. This is not a general rename/transfer sell-through grace period or permission to first place changed devices under obsolete labels.