United Kingdom medical device regulations

The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In the MD sheet REF is mandatory; in the IVD sheet it is optional. Populated UDI identity fields have stricter mutability. The device guide requires removing and re-adding a product for a disabled product field, or removing and re-registering the device and its underlying products for a disabled device field. The public registration guidance expressly lists trade/brand-name and non-editable characteristic changes as re-registration triggers.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.

DORS organisation name and address edits are permitted only where the legal entity remains the same, and are free. A UKRP or NI representative changing its own details must supply updated designation letters for represented manufacturers; a representative editing a represented manufacturer must upload a new designation letter. Those designation-dependent changes are applied after MHRA review and acceptance. A UK manufacturer acting for itself does not need a designation letter.

The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In the MD sheet REF is mandatory; in the IVD sheet it is optional. Populated UDI identity fields have stricter mutability. The device guide requires removing and re-adding a product for a disabled product field, or removing and re-registering the device and its underlying products for a disabled device field. The public registration guidance expressly lists trade/brand-name and non-editable characteristic changes as re-registration triggers.

For ordinary NI devices under MDR or IVDR, the economic operator updates changed registered actor data within one week under MDR 31(4) or IVDR 28(4). A Local Actor Administrator creates and registers a new version of the actor details. Tax/trade-ID changes have a separate authority-validated request and pending-request lock. A person not already registered must satisfy the applicable premarket actor-registration requirement; an existing-actor edit does not itself prove succession to another legal manufacturer’s conformity evidence.

For ordinary Northern Ireland devices under the EU regime, 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.

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.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.

DORS organisation name and address edits are permitted only where the legal entity remains the same, and are free. A UKRP or NI representative changing its own details must supply updated designation letters for represented manufacturers; a representative editing a represented manufacturer must upload a new designation letter. Those designation-dependent changes are applied after MHRA review and acceptance. A UK manufacturer acting for itself does not need a designation letter.

The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In the MD sheet REF is mandatory; in the IVD sheet it is optional. Populated UDI identity fields have stricter mutability. The device guide requires removing and re-adding a product for a disabled product field, or removing and re-registering the device and its underlying products for a disabled device field. The public registration guidance expressly lists trade/brand-name and non-editable characteristic changes as re-registration triggers.

For ordinary NI devices under MDR or IVDR, the economic operator updates changed registered actor data within one week under MDR 31(4) or IVDR 28(4). A Local Actor Administrator creates and registers a new version of the actor details. Tax/trade-ID changes have a separate authority-validated request and pending-request lock. A person not already registered must satisfy the applicable premarket actor-registration requirement; an existing-actor edit does not itself prove succession to another legal manufacturer’s conformity evidence.

For ordinary Northern Ireland devices under the EU regime, 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.

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.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.

The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In the MD sheet REF is mandatory; in the IVD sheet it is optional. Populated UDI identity fields have stricter mutability. The device guide requires removing and re-adding a product for a disabled product field, or removing and re-registering the device and its underlying products for a disabled device field. The public registration guidance expressly lists trade/brand-name and non-editable characteristic changes as re-registration triggers.

For ordinary Northern Ireland devices under the EU regime, 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.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.

The same-entity name/address editor excludes a change of legal person. Identify the manufacturer that will take responsibility for conformity and place the affected devices under its name, the applicable conformity evidence and the correct GB registration before market placement. A UKRP change separately requires a new registration, with new designation evidence; it does not itself transfer the legal manufacturer or establish continuity of an old conformity certificate. In NI the responsible manufacturer, actor/device registration and representative arrangements follow the applicable EU regime.

For ordinary Northern Ireland devices under the EU regime, 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.

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.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.

The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In the MD sheet REF is mandatory; in the IVD sheet it is optional. Populated UDI identity fields have stricter mutability. The device guide requires removing and re-adding a product for a disabled product field, or removing and re-registering the device and its underlying products for a disabled device field. The public registration guidance expressly lists trade/brand-name and non-editable characteristic changes as re-registration triggers.

For ordinary NI devices under MDR or IVDR, the economic operator updates changed registered actor data within one week under MDR 31(4) or IVDR 28(4). A Local Actor Administrator creates and registers a new version of the actor details. Tax/trade-ID changes have a separate authority-validated request and pending-request lock. A person not already registered must satisfy the applicable premarket actor-registration requirement; an existing-actor edit does not itself prove succession to another legal manufacturer’s conformity evidence.

For ordinary Northern Ireland devices under the EU regime, 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.

For a manufacturer or device registration/re-registration, provide the legal-entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version, REF and UDI information where applicable, and the relevant conformity certificate or declaration. A represented organisation also needs the applicable designation evidence. For an ordinary same-person organisation edit use the change-specific designation-letter rules; this is not a universal new technical dossier for every REF correction.

From 1 April 2026 no separate statutory fee is charged for organisation name/address updates or new designation-letter uploads. Adding/removing products under registered devices, updating editable fields and obsolete GMDN data, and adding/deactivating importers are also uncharged as specified. Re-registration following a changed characteristic is charged only where it adds a chargeable new GMDN category under the current fee rules; this is not a per-REF or per-brand variation tariff.

For GB choose the actual UKCA or accepted-CE conformity route. When UKCA is affixed, including a dual-marked device, the UKRP name and address must be on the product labelling, outer packaging or instructions for use. NI devices must meet EU labelling requirements. A brand artwork revision does not remove mandatory device/manufacturer/representative identifiers or validate a mismatched conformity record.

A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK-based manufacturer, UKRP or NI authorised representative for DORS-registered eligible devices with valid conformity evidence; performance-evaluation IVDs are excluded. Correct product name, model/version and REF before ordering. A pending managed-device application blocks CFS for affected devices. The published target is 10 working days from receipt, longer during busy periods; that is a CFS service target, not a variation-review deadline.

For ordinary Northern Ireland devices under the EU regime, 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.

For ordinary Northern Ireland devices under the EU regime, 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.

For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.

£300

Per chargeable GMDN category, annual (pro rata for registration during the fee year)

Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee.

£75

Per order (first 10 certificates)

£75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date.