Use of EUDAMED is expected to be published in the Official Journal of the EU (OJEU) in Q2 2027. Afterward, a 24-month transition period will apply for the UDI/Device registration module, making it mandatory in Q2 2029.

After the 24-month transition period ends, all CE Marked medical devices and IVDs, including legacy devices, must be registered in EUDAMED.

The exact compliance date will depend on the day EUDAMED is published in the OJEU.

More information can be found: HERE

The device must either be MDR CE Marked or UKCA Marked to continue being placed on the Great Britain (England, Scotland, Wales) market after this date. 

IVDD CE Marked devices have a further two (2) years transition period.

Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking. 

Use of EUDAMED is expected to be published in the Official Journal of the EU in Q2 2027. Afterward, a six-month transition period will apply for the Economic Operator registration module (i.e., manufacturers, system/procedure pack producers, authorized representatives and importers).

It becomes mandatory in Q4 2027. After the six-month transition period ends, all manufacturers of CE Marked medical devices and IVDs, including legacy devices, are required to have registered in EUDAMED. Registration of Economic Operators is completed in the EUDAMED Actor module.

More information can be found: HERE

UDI carrier required on Class A IVD labeling. Not applicable to IVDD legacy devices.

EUDAMED is scheduled to be ‘fully functional’ sometime in Q2 2027. This means that all six modules of EUDAMED have been built out and EUDAMED as a whole has passed an independent audit. It would then be published in the Official Journal of the European Union (OJEU). After publication in the OJEU, the 6-24 month transition period begins.

There is a six-month transition period for the following modules: Actor, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance. There is a 24-month transition period for the following modules: UDI/Device and Notified Body & Certificates modules.

The transition period ends for IVDD legacy devices that are Class C under the IVDR.

IVDD legacy devices lawfully placed on the market prior to 26 May 2026 may continue to be supplied and put into service.

The transition period ends for IVDD legacy devices that are Class D under the IVDR.

IVDD legacy devices lawfully placed on the market prior to 26 May 2025 may continue to be supplied and put into service.

UDI carrier required on MDR Class I medical devices and IVDR Class B/C IVD labeling. Not applicable to MDD/IVDD legacy devices.

By today, all MDD/AIMDD legacy device manufacturers must have a signed written agreement with a Notified Body, as per Section 4.3, second subparagraph, of Annex VII.

Swissmedic will release its own registration database. The reason is that, due to the lapsed Mutual Recognition Agreement with Europe for medical devices and IVDs, Swissmedic no longer has Competent Authority level access to EUDAMED.

In an effort toward the “continuing aim of equivalence between regulations in Switzerland and the EU“, swissmdamed’s Economic Operator and Device Registration modules will be similar to the corresponding EUDAMED modules.

The ‘go-live’ is planned for 2024. It will initially only be available for voluntary use. Once the Medical Device and IVD Ordinances are amended, then swissmadmed will become mandatory. 

For more information, including timelines, please read: Swissdamed Registration Database

All vigilance must now be reported through the new version of the Manufacturer’s On-Line Reporting Environment (MORE) vigilance portal. The old MORE portal has been obsoleted. 

In the meantime, manufacturers may still continue to submit vigilance to the MHRA by email. 

For more information on how to create an account, please read: MORE Vigilance Platform, New Account Creation Guide

The MHRA will implement new post-market surveillance (PMS) requirements in Great Britain, prior to the release of the new Regulation (currently expected sometime in 2025). 

The PMS legislation is expected to be published in 2023, followed by a transition period. The anticipated implementation deadline is by the end of 2024. 

NOTE: the PMS requirements will be applicable for both UKCA and CE Marked devices.

UDI Direct Marking required for Class III and reusable implantable MDR devices. Not applicable to MDD/AIMDD legacy devices.

Class B and C IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

IVDR not intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 March 2025. Starting 1 April 2025, the CH-REP must be identified on the label.

IVDR devices already on the Swiss market before 26 May 2022 have until 31 March 2023 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.

IVDR intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label. IVDR devices already on the Swiss market before 26 May 2022 have until 31 December 2022 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.  

IVDD already marketed in Switzerland before 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 March 2023.

IVDD newly marketed in Switzerland after 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

Class D IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

IVDR not intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 March 2025. Starting 1 April 2025, the CH-REP must be identified on the label.

IVDR devices already on the Swiss market before 26 May 2022 have until 31 December 2022 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.

IVDR intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label. IVDR devices already on the Swiss market before 26 May 2022 have until 31 December 2022 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.  

IVDD already marketed in Switzerland before 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 March 2023.

IVDD newly marketed in Switzerland after 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to medical devices. Swissmedic, therefore, instituted its own importer requirements.

The transition period implemented for importers to identify themselves with MDD/AIMDD legacy devices is now over. The importer must be identified on the device, the packaging, or in a document accompanying the device.

On the IVDR’s date of application, the Swiss-EU Mutual Recognition Agreement (MRA) for IVDs lapsed.

Due to larger political reasons, the MRA does not include a provision for the In Vitro medical device Regulation (IVDR). Therefore, Switzerland becomes a ‘third country’ to Europe as it relates to IVDs.

Swiss manufacturers require an EU Authorized Representative (AR) to market in the EU and all non-Swiss manufacturers require a Swiss Authorized Representative to market in Switzerland. Swissmedic provides a transition period to appoint the CH-REP. The EU does not provide a transition period.

Swissmedic has implemented the IVDR into its legislation, other than the country-specific differences, such as the appointment of a Swiss AR instead of an EU AR.

Class IIb non-implantable and Class IIa device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.

MDR devices already on the Swiss market before 26 May 2021 have until 31 March 2022 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2021 must immediately identify the CH-REP. 

MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 March 2022.

MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

Class III/AIMD and Class IIb implantable device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.

MDR devices already on the Swiss market before 26 May 2022 have until 31 December 2021 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP. 

MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.

MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

AIMDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.

AIMDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland.

Released for voluntary use. The EUDAMED Device/UDI & Notified Body (NB)/Certificates Registration Modules are not expected to be mandatory until 2029.

UDI carrier required on MDR Class III and implantable device labeling. Not applicable to MDD/AIMDD legacy devices.

Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to medical devices. Swissmedic, therefore, instituted its own importer requirements.

A transition period is implemented for importers to identify themselves with MDD/AIMDD legacy devices. However, no such transition period is granted for MDR CE Marked devices and Swiss importers must identify themselves immediately. The importer may be identified on the device, the packaging, or in a document accompanying the device.

AIMD, Class III, Class IIb implantable devices and Annex II, List A IVDs must be registered by this date. 

The UK Responsible Person (UKRP) must complete the registration, if the manufacturer is established outside of the UK.

Released for voluntary use. The EUDAMED Actor Registration Module is not expected to be mandatory until 2027.

The MDR is postponed by one year.

MDD legacy devices are no longer recognized. To continue placing these devices on the market, they must be CE Marked to the MDR.

Use of EUDAMED is expected to be published in the Official Journal of the EU in Q2 2027. Afterward, a six-month transition period will apply for the Economic Operator registration module (i.e., manufacturers, system/procedure pack producers, authorized representatives and importers).

It becomes mandatory in Q4 2027. After the six-month transition period ends, all manufacturers of CE Marked medical devices and IVDs, including legacy devices, are required to have registered in EUDAMED. Registration of Economic Operators is completed in the EUDAMED Actor module.

More information can be found: HERE

The transition period ends for IVDD legacy devices that are Class B or Class A sterile under the IVDR.

IVDD legacy devices lawfully placed on the market prior to 26 May 2027 may continue to be supplied and put into service.

EUDAMED is scheduled to be ‘fully functional’ sometime in Q2 2027. This means that all six modules of EUDAMED have been built out and EUDAMED as a whole has passed an independent audit. It would then be published in the Official Journal of the European Union (OJEU). After publication in the OJEU, the 6-24 month transition period begins.

There is a six-month transition period for the following modules: Actor, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance. There is a 24-month transition period for the following modules: UDI/Device and Notified Body & Certificates modules.

The transition period ends for IVDD legacy devices that are Class C under the IVDR.

IVDD legacy devices lawfully placed on the market prior to 26 May 2026 may continue to be supplied and put into service.

UDI Direct Marking required for Class IIa and IIb reusable MDR devices. Not applicable to MDD legacy devices.

By today, all MDD/AIMDD legacy device manufacturers must have a signed written agreement with a Notified Body, as per Section 4.3, second subparagraph, of Annex VII.

If you have not already done so, it is strongly recommended that MDD/AIMDD legacy device manufacturers reach out to Notified Bodies ASAP to request quotes. Notified Bodies are in high demand, and response times for service quotes may be long.

UDI Direct Marking required for Class III and reusable implantable MDR devices. Not applicable to MDD/AIMDD legacy devices.

All devices new to the market must be CE Marked to the IVDR.

All Class A non-sterile IVD devices require IVDR CE Marking as of 26 May 2022.

A transition period is granted for all other IVD devices. Certain conditions apply. Please see the rest of the timeline chart for the other IVDR compliance dates.

The IVDR is not delayed outright (like the MDR was). Instead, the EU institutes a longer transition period for most IVDD legacy devices; exact dates depend on the device classification.

UDI carrier required on MDR Class III and implantable device labeling. Not applicable to MDD/AIMDD legacy devices.

• All devices new to the market must be CE Marked to the MDR.
• All devices that are Class I self-certified under both MDD and MDR, must be CE Marked to the MDR as of today to continue being placed onto the market.
• MDD Class I self-certified devices which were up-classed under the MDR and Class I sterile/measuring, IIa, IIb and III devices with valid MDD/AIMDD Notified Body issued CE Marking may continue marketing through the transition periods outlined in MDR Article 120(3). Certain conditions apply – click here for more information.

Released for voluntary use. The EUDAMED Actor Registration Module is not expected to be mandatory until 2027.

The EU Commission announces EUDAMED will be delayed. For the most current EUDAMED timeframes, please read: Commission Publishes New EUDAMED Timeline: Delayed Until at Least 2027

The device must either be MDR CE Marked or UKCA Marked to continue being placed on the Great Britain (England, Scotland, Wales) market after this date. 

IVDD CE Marked devices have a further two (2) years transition period.

Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking. 

All vigilance must now be reported through the new version of the Manufacturer’s On-Line Reporting Environment (MORE) vigilance portal. The old MORE portal has been obsoleted. 

In the meantime, manufacturers may still continue to submit vigilance to the MHRA by email. 

For more information on how to create an account, please read: MORE Vigilance Platform, New Account Creation Guide

The UK government announced that the new UK legislation and the UKCA Marking deadline of 1 July 2023 would be postponed. The new deadline for the updated UK medical device legislation is sometime in 2025. Further, the MHRA will continue to recognize European CE Marking for an extended transition period: 2028-2030 depending on the type of device.

This does not exempt manufacturers from appointing a UK Responsible Person (if non-UK-based) and registering their devices with the MHRA. It simply means the MHRA will accept device registrations based on CE Marking.

NOTE: the postponement does not mean companies cannot UKCA Mark until the deadline. Manufacturers may opt to UKCA Mark today if they wish; however, they are not obligated to do so.

Class IIb Non-implantable, Class IIa medical devices and Annex II, List B and Self-test IVDs must be registered by this date. 

The UK Responsible Person (UKRP) must complete the registration, if the manufacturer is established outside of the UK.

The UK is no longer recognized as part of the EU.

Manufacturers in Great Britain (England, Scotland, Wales) require an EU Authorized Representative to continue marketing in the EU, and EU manufacturers must appoint a UK Responsible Person and register their devices with the UK MHRA.

The MHRA provides a one-year transition period to register devices, exact dates depend on the device classification. The EU does not provide a transition period.

The extension period is over for all Class III devices and all Class IIb implantable devices, except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.

In order to continue placing these devices on the market, they must be CE Marked to the MDR.

UDI carrier required on Class A IVD labeling. Not applicable to IVDD legacy devices.

By today, Class III implantable custom-made devices (CMDs) must comply with the MDR in order to continue being placed on the EU and Swiss markets, i.e., the device must possess a conformity assessment certificate issued by a Notified Body.

The transition period ends for IVDD legacy devices that are Class D under the IVDR.

IVDD legacy devices lawfully placed on the market prior to 26 May 2025 may continue to be supplied and put into service.

UDI carrier required on MDR Class I medical devices and IVDR Class B/C IVD labeling. Not applicable to MDD/IVDD legacy devices.

By today, all MDD/AIMDD legacy device manufacturers must have a signed written agreement with a Notified Body, as per Section 4.3, second subparagraph, of Annex VII.

Swissmedic will release its own registration database. The reason is that, due to the lapsed Mutual Recognition Agreement with Europe for medical devices and IVDs, Swissmedic no longer has Competent Authority level access to EUDAMED.

In an effort toward the “continuing aim of equivalence between regulations in Switzerland and the EU“, swissmdamed’s Economic Operator and Device Registration modules will be similar to the corresponding EUDAMED modules.

The ‘go-live’ is planned for 2024. It will initially only be available for voluntary use. Once the Medical Device and IVD Ordinances are amended, then swissmadmed will become mandatory. 

For more information, including timelines, please read: Swissdamed Registration Database

Class A IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

IVDR not intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 March 2025. Starting 1 April 2025, the CH-REP must be identified on the label.

IVDR devices already on the Swiss market before 26 May 2022 have until 31 July 2023 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.

IVDD already marketed in Switzerland before 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 July 2023.

IVDD newly marketed in Switzerland after 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

UDI Direct Marking required for Class III and reusable implantable MDR devices. Not applicable to MDD/AIMDD legacy devices.

Regulation 2023/607 formally extends the Article 120 transitional provisions in the MDR. It also removes the sell-off period from the MDR and IVDR.

The extension allows, under certain criteria:

1. For devices with expired MDD/AIMDD CE Marking certificates to be considered valid and remain on the market.
2. For Class III implantable custom-made devices to be granted an extension to comply with the MDR.

Certain conditions apply.

Class I device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.

MDR devices already on the Swiss market before 26 May 2021 have until 31 July 2022 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2021 must immediately identify the CH-REP. 

MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 July 2022.

MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

All devices new to the market must be CE Marked to the IVDR.

All Class A non-sterile IVD devices require IVDR CE Marking as of 26 May 2022.

A transition period is granted for all other IVD devices. Certain conditions apply. Please see the rest of the timeline chart for the other IVDR compliance dates.

Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to IVDs. Swissmedic, therefore, instituted its own importer requirements. 

Swiss importers must identify themselves immediately for IVD devices. The importer may be identified on the device, the packaging, or in a document accompanying the device.

Class III/AIMD and Class IIb implantable device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.

MDR devices already on the Swiss market before 26 May 2022 have until 31 December 2021 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP. 

MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.

MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

AIMDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.

AIMDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland.

On the MDR’s date of application, the Swiss-EU Mutual Recognition Agreement (MRA) for medical devices lapsed. Due to larger political reasons, the MRA does not include a provision for the Medical Device Regulation (MDR). Therefore, Switzerland becomes a ‘third country’ to Europe as it relates to medical devices.

Swiss manufacturers require an EU Authorized Representative (AR) to market in the EU and all non-Swiss manufacturers require a Swiss Authorized Representative to market in Switzerland. Swissmedic provides a transition period to appoint the CH-REP. The EU does not provide a transition period.

Swissmedic has implemented the MDR into its legislation, other than the country-specific, such as the appointment of a Swiss AR instead of an EU AR.

• All devices new to the market must be CE Marked to the MDR.
• All devices that are Class I self-certified under both MDD and MDR, must be CE Marked to the MDR as of today to continue being placed onto the market.
• MDD Class I self-certified devices which were up-classed under the MDR and Class I sterile/measuring, IIa, IIb and III devices with valid MDD/AIMDD Notified Body issued CE Marking may continue marketing through the transition periods outlined in MDR Article 120(3). Certain conditions apply – click here for more information.