Switzerland medical device regulations

Under MedDO 17(4) and its incorporated MDR clauses, 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.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

A foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year

For a company synchronised with the UID register/Zefix, correct the company name or address there first; swissdamed receives the update automatically. For a manually registered company or one that opted out of synchronisation, the current FAQ describes the Registered companies pencil editor and directs company-name changes to Swissmedic support. The Actors guide separately directs support for company data that cannot be edited through the actor profile. Other actor details are updated by the authorised user and confirmed. A name/address edit does not establish transfer to a different manufacturer.

MDCG 2020-3 Rev.1 distinguishes administrative manufacturer name/address/legal-form changes from significant design/intended-purpose changes for legacy MDs. Its merger/acquisition example expressly requires the legal entity certified under the directives to continue to exist; transfer to another manufacturer marketing under MDR is excluded. Observe the agreed notified-body notification procedure and any written confirmation of continuing certificate validity.

A foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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 MedDO 17(4) and its incorporated MDR clauses, 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.

The current swissdamed data dictionary distinguishes manufacturer SRN, Basic UDI-DI, UDI-DI, model/name, trade names and catalogue/REF. Its Updateable legend says blank means No: the REF field FLD-UDID-163 is not updateable in this version for either MD or IVD, while trade names have explicit edit/add/delete permission. The manufacturer SRN is expressly non-updateable in the business rules. Discarding a registered UDI is only for incorrect data that cannot be corrected by updating, not a general workaround for a real commercial or legal-manufacturer change.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year

For a company synchronised with the UID register/Zefix, correct the company name or address there first; swissdamed receives the update automatically. For a manually registered company or one that opted out of synchronisation, the current FAQ describes the Registered companies pencil editor and directs company-name changes to Swissmedic support. The Actors guide separately directs support for company data that cannot be edited through the actor profile. Other actor details are updated by the authorised user and confirmed. A name/address edit does not establish transfer to a different manufacturer.

MDCG 2020-3 Rev.1 distinguishes administrative manufacturer name/address/legal-form changes from significant design/intended-purpose changes for legacy MDs. Its merger/acquisition example expressly requires the legal entity certified under the directives to continue to exist; transfer to another manufacturer marketing under MDR is excluded. Observe the agreed notified-body notification procedure and any written confirmation of continuing certificate validity.

A foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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 MedDO 17(4) and its incorporated MDR clauses, 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.

The current swissdamed data dictionary distinguishes manufacturer SRN, Basic UDI-DI, UDI-DI, model/name, trade names and catalogue/REF. Its Updateable legend says blank means No: the REF field FLD-UDID-163 is not updateable in this version for either MD or IVD, while trade names have explicit edit/add/delete permission. The manufacturer SRN is expressly non-updateable in the business rules. Discarding a registered UDI is only for incorrect data that cannot be corrected by updating, not a general workaround for a real commercial or legal-manufacturer change.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year

Under MedDO 17(4) and its incorporated MDR clauses, 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 foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year

MDCG 2020-3 Rev.1 distinguishes administrative manufacturer name/address/legal-form changes from significant design/intended-purpose changes for legacy MDs. Its merger/acquisition example expressly requires the legal entity certified under the directives to continue to exist; transfer to another manufacturer marketing under MDR is excluded. Observe the agreed notified-body notification procedure and any written confirmation of continuing certificate validity.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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 MedDO 17(4) and its incorporated MDR clauses, 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.

The current swissdamed data dictionary distinguishes manufacturer SRN, Basic UDI-DI, UDI-DI, model/name, trade names and catalogue/REF. Its Updateable legend says blank means No: the REF field FLD-UDID-163 is not updateable in this version for either MD or IVD, while trade names have explicit edit/add/delete permission. The manufacturer SRN is expressly non-updateable in the business rules. Discarding a registered UDI is only for incorrect data that cannot be corrected by updating, not a general workaround for a real commercial or legal-manufacturer change.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year

Under MedDO 17(4) and its incorporated MDR clauses, 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 foreign manufacturer needs a Swiss-established CH-REP under a written mandate: MedDO Article 51 for MD and IvDO Article 44 for IVD. The responsible manufacturer must meet the applicable conformity, technical-documentation and declaration duties. A different legal manufacturer cannot be substituted by editing the non-updateable manufacturer SRN. A transfer of the CH-REP mandate and its registered devices is a separate representative workflow and does not itself prove that a new manufacturer succeeds to the former manufacturer’s conformity evidence.

Under MedDO 23 and incorporated MDR Annex IX, 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 4.10, 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.

Updating data for an already registered UDI-DI incurs no new device registration fee. Re-registering a discarded UDI-DI is fee-bearing under the current registration schedule. Actor data changes are usually free, but Swissmedic intervention may be charged on actual time at CHF 270 per hour. A new UDI/device registration resulting from the actual identity change must not be presented as a free data update.

A new FSC costs CHF 200 per certificate. Additional resources for product lists over 100 pages may be charged; cancellation/withdrawal or an uncompleted rejected order can attract the stated CHF 100 reduced charge. Swissmedic issues an FSC within 30 days after receipt of the order and complete, appropriate electronic documentation. An incomplete application has a separate 30-day response deadline. These are FSC conditions, not a general identity-variation fee or review clock.

Under MedDO 16 and incorporated MDR label requirements, 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.

MD labelling and instructions are generally required in German, French and Italian. Fewer official languages or English is permitted only where all MedDO 16(3) conditions are met: the stated professional-use/custom-made/Art 9 branch, the user has the necessary professional and language skills and agrees, protection is ensured, and safe/effective use is not jeopardised. Additional information in an official language must be provided on request.

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.

If an export destination requires an FSC, a Swiss-established manufacturer or authorised representative may apply. Update supporting documents for a company name/address change before ordering. The product list identifies the single legal manufacturer, CHRN, product name, REF/article number, class and applicable UDI/conformity references. Current-law and legacy-law products require separate orders; no mixed order is accepted. Orders processed from 1 January 2027 require the listed devices to be registered in swissdamed. This export requirement is separate from an ordinary identity-data update.

For an FSC covering current MedDO devices, the class table requires a declaration of conformity. Ordinary Class I has no notified-body certificate entry; Im, Ir and Is and higher classes require the appropriate class/route certificates identified in the table. For qualifying legacy MDs, use the legacy evidence and the notified-body transition confirmation described in the guide; the legacy declaration must have been signed before 26 May 2021. A new identity must be reflected in the supporting documents before an export-certificate order.

CHF 200

First UDI-DI per manufacturer per calendar year

CHF 20

Each additional UDI-DI in the same calendar year

Maximum CHF 10,000 per manufacturer per year