Timeline – All Markets

2030
UK: Last Date MHRA Accepts CE Marking
All devices must be UKCA Marked to continue being placed on the Great Britain market. CE Marking, under either the Directives and Regulations, is no longer recognized in Great Britain (England, Scotland, Wales).   Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking. 
2029
EUDAMED Device Registration

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

2028
MDR Compliance Date: Class IIb, IIa, I devices

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

UK: MDD/AIMDD Devices No Longer Accepted

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. 

2027
MDR Compliance Date: Class III, IIb implantable

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.

EUDAMED Actor Registration

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

IVDR Compliance Date: Class B/A sterile

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.

UDI Carrier: Class A IVDs

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

UDI Direct Marking: Low-Risk

UDI Direct Marking required for Class I reusable MDR devices. Not applicable to MDD legacy devices.

EUDAMED Expected to be Fully Functional

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.

2026
Class III Implantable CMD Compliance Date

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.

IVDR Compliance Date: Class C

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.

2025
New UK Regulation Implementation Date

The new UK medical device regulation is expected to come into force in 2025. The exact date is unknown.

 

The new legislation will only apply in Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking. 

IVDR Compliance Date: Class D

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 Direct Marking: Mid-Risk

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

UDI Carrier: Class I & Class B/C IVDs

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

CH REP: Add Directly to IVDR Labels

IVDR CE Marked IVDs have a transition period to apply the Swiss Authorized Representative (CH REP) information directly on the product labels. Before 31 March 2025, the CH REP information may be supplied on the label, or in a document accompanying the device. After 31 March 2025, it must be on the labels. 

 

This transition period does not apply to self-test IVDs CE Marked under the IVDR. These devices must identify the CH REP on the product labels immediately, as soon as they are placed onto the Swiss market. 

2024
Have Signed Agreement with Notified Body

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.

Implement MDR QMS & Lodge NB Application

By today, manufacturers of MDD/AIMDD legacy devices must have:

 

  1. implemented a quality management system as outlined in MDR Article 10(9) and
  2. formally lodged an application with a Notified Body for the device. Otherwise, the device no longer qualifies as a legacy device under the extension. 

NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date.

‘Swissdamed’ Database to be Released in 2024

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

RECOMMENDATION: Contact NBs for Quotes

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.

2023
New UK MHRA Vigilance Portal

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

Swiss AR Deadline: Class A IVDs

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. 

New UK Post-Market Surveillance Requirements

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.

Original UKCA Marking Deadline

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.

UDI Carrier: Class IIb/IIa and IVD Class D

UDI carrier required on MDR Class IIa and IIb medical devices and Class D IVD labeling. Not applicable to MDD/IVDD legacy devices.

 

UDI Direct Marking: High-Risk

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

Swiss AR Deadline: Class B/C IVDs

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. 

Regulation 2023/607 Published

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.

2022
Swiss AR Deadline: Class D IVDs

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. 

Swiss AR Appointment Deadline: Class I

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. 

 

Swiss Importer Identified with MDD/AIMDD

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.

IVDR Date of Application

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.

Swiss-EU MRA Lapses for IVDs

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.

Swiss Importer Identified with IVD Devices

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.

Swiss AR Deadline: Class IIb non-implantable/IIa

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. 

 

UK Registration Deadline: Low-Risk Devices

Class I medical devices, General IVDs and Custom-made Devices must be registered by this date. 

 

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

2021
Swiss AR Deadline: Class III/IIb Implantable

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.

 

 

EU Adopts Delays to Some Aspects of IVDR

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.

EUDAMED Device & NB/Certificates Modules

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

UK Registration Deadline: Mid-Risk Devices

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.

 

 

UDI Carrier: Class III & Implantable Devices

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

Swiss-EU MRA Lapses for Medical Devices

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.

Swiss Importer Identified with MDR 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.

MDR Date of Application
  • 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.
UK Registration Deadline: High-Risk Devices

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.

“Brexit” Transition Period Ends

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.

2020
EUDAMED Actor Registration Module

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

Original MDR Date of Application

The MDR is postponed by one year.

Original EUDAMED Implementation Date

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

Timeline – EU Only

2029
EUDAMED Device Registration

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

2028
MDR Compliance Date: Class IIb, IIa, I devices

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

2027
MDR Compliance Date: Class III, IIb implantable

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.

EUDAMED Actor Registration

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

IVDR Compliance Date: Class B/A sterile

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.

UDI Carrier: Class A IVDs

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

UDI Direct Marking: Low-Risk

UDI Direct Marking required for Class I reusable MDR devices. Not applicable to MDD legacy devices.

EUDAMED Expected to be Fully Functional

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.

2026
Class III Implantable CMD Compliance Date

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.

IVDR Compliance Date: Class C

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.

2025
IVDR Compliance Date: Class D

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 Direct Marking: Mid-Risk

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

UDI Carrier: Class I & Class B/C IVDs

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

2024
Have Signed Agreement with Notified Body

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.

Implement MDR QMS & Lodge NB Application

By today, manufacturers of MDD/AIMDD legacy devices must have:

 

  1. implemented a quality management system as outlined in MDR Article 10(9) and
  2. formally lodged an application with a Notified Body for the device. Otherwise, the device no longer qualifies as a legacy device under the extension. 

NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date.

RECOMMENDATION: Contact NBs for Quotes

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.

2023
UDI Carrier: Class IIb/IIa and IVD Class D

UDI carrier required on MDR Class IIa and IIb medical devices and Class D IVD labeling. Not applicable to MDD/IVDD legacy devices.

 

UDI Direct Marking: High-Risk

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

Regulation 2023/607 Published

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.

2022
IVDR Date of Application

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.

Swiss-EU MRA Lapses for IVDs

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.

2021
EU Adopts Delays to Some Aspects of IVDR

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.

EUDAMED Device & NB/Certificates Modules

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

UDI Carrier: Class III & Implantable Devices

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

Swiss-EU MRA Lapses for Medical Devices

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.

MDR Date of Application
  • 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.
“Brexit” Transition Period Ends

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.

2020
EUDAMED Actor Registration Module

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

Original MDR Date of Application

The MDR is postponed by one year.

Original EUDAMED Implementation Date

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

“Brexit”: UK Withdraws from the EU

The UK officially withdraws from the European Union. An 11-month transition period commences.

Timeline – UK Only

2030
UK: Last Date MHRA Accepts CE Marking

All devices must be UKCA Marked to continue being placed on the Great Britain market. CE Marking, under either the Directives and Regulations, is no longer recognized in Great Britain (England, Scotland, Wales).

 

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

2028
UK: MDD/AIMDD Devices No Longer Accepted

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. 

2025
New UK Regulation Implementation Date

The new UK medical device regulation is expected to come into force in 2025. The exact date is unknown.

 

The new legislation will only apply in Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking. 

2023
New UK MHRA Vigilance Portal

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

New UK Post-Market Surveillance Requirements

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.

Original UKCA Marking Deadline

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.

2022
UK Registration Deadline: Low-Risk Devices

Class I medical devices, General IVDs and Custom-made Devices must be registered by this date. 

 

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

2021
UK Registration Deadline: Mid-Risk Devices

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.

 

 

UK Registration Deadline: High-Risk Devices

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.

“Brexit” Transition Period Ends

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.

2020
“Brexit”: UK Withdraws from the EU

The UK officially withdraws from the European Union. An 11-month transition period commences.

Timeline – Switzerland Only

2028
MDR Compliance Date: Class IIb, IIa, I devices

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

2027
MDR Compliance Date: Class III, IIb implantable

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: Class A IVDs

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

UDI Direct Marking: Low-Risk

UDI Direct Marking required for Class I reusable MDR devices. Not applicable to MDD legacy devices.

IVDR Compliance Date: Class B/A sterile

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.

2026
Class III Implantable CMD Compliance Date

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.

IVDR Compliance Date: Class C

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.

2025
IVDR Compliance Date: Class D

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 Direct Marking: Mid-Risk

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

UDI Carrier: Class I & Class B/C IVDs

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

CH REP: Add Directly to IVDR Labels

IVDR CE Marked IVDs have a transition period to apply the Swiss Authorized Representative (CH REP) information directly on the product labels. Before 31 March 2025, the CH REP information may be supplied on the label, or in a document accompanying the device. After 31 March 2025, it must be on the labels. 

 

This transition period does not apply to self-test IVDs CE Marked under the IVDR. These devices must identify the CH REP on the product labels immediately, as soon as they are placed onto the Swiss market. 

2024
Have Signed Agreement with Notified Body

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.

Implement MDR QMS & Lodge NB Application

By today, manufacturers of MDD/AIMDD legacy devices must have:

 

  1. implemented a quality management system as outlined in MDR Article 10(9) and
  2. formally lodged an application with a Notified Body for the device. Otherwise, the device no longer qualifies as a legacy device under the extension. 

NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date.

‘Swissdamed’ Database to be Released in 2024

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

RECOMMENDATION: Contact NBs for Quotes

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.

2023
Swiss AR Deadline: Class A IVDs

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 Carrier: Class IIb/IIa and IVD Class D

UDI carrier required on MDR Class IIa and IIb medical devices and Class D IVD labeling. Not applicable to MDD/IVDD legacy devices.

 

UDI Direct Marking: High-Risk

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

Swiss AR Deadline: Class B/C IVDs

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. 

Regulation 2023/607 Published

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.

2022
Swiss AR Deadline: Class D IVDs

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. 

Swiss AR Appointment Deadline: Class I

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. 

 

Swiss Importer Identified with MDD/AIMDD

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.

IVDR Date of Application

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.

Swiss-EU MRA Lapses for IVDs

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.

Swiss Importer Identified with IVD Devices

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.

Swiss AR Deadline: Class IIb non-implantable/IIa

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. 

 

2021
Swiss AR Deadline: Class III/IIb Implantable

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.

 

 

UDI Carrier: Class III & Implantable Devices

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

Swiss-EU MRA Lapses for Medical Devices

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.

Swiss Importer Identified with MDR 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.

MDR Date of Application
  • 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.
2020
Original MDR Date of Application

The MDR is postponed by one year.

Important Dates – ALL

For the purpose of this page, “Europe” = the EU-27, Iceland, Liechtenstein, Norway, Northern Ireland, and Turkey.

    • 31 January 2020 – UK officially withdraws from the European Union (“Brexit”)
    • 26 May 2020 – Original MDR date of application, postponed one year
    • 26 May 2020 – Original EUDAMED implementation date, postponed two years
    • 1 December 2020 – EUDAMED Actor Registration Module released on voluntary use basis
    • 1 January 2021 – Brexit Transition period ends, UK is no longer recognized as part of the EU (UK manufacturers require an EU AR and non-UK companies require a UK Responsible Person (UKRP). CE Marking is still accepted in the four UK countries until 2028-2030, depending on the type of device.
    • 1 May 2021 – UK Registration deadline for Class III/AIMD/IIb implantable/IVD List A devices
    • 26 May 2021 – MDR date of application, some transitional provisions apply*
    • 26 May 2021 – Switzerland-EU Mutual Recognition for medical devices ceases (non-Swiss companies require a Swiss AR and importer to market in Switzerland; Swiss manufacturers require an EU AR and EU Importer)**
    • 26 May 2021 – Swiss importer must be identified on the device, its packaging, or in a document accompanying the device for MDR products; MDD/AIMDD devices have a further transition period
    • 26 May 2021 – UDI carrier required on labeling for MDR Class III and Implantable devices
    • 1 September 2021 – UK registration deadline for Class IIb non-implantable/Class IIa/IVD List B/IVD self-test devices
    • 4 October 2021 – EUDAMED Device/UDI & Notified Body/Certificates registration modules released on voluntary use basis
    • 15 December 2021 – EU Parliament adopts delays to some aspects of IVDR
    • 31 December 2021 – Swiss AR appointment deadline for Class III/AIMD/IIb implantable devices**
    • 1 January 2022 – UK registration deadline for Class I/General IVD/custom-made devices
    • 31 March 2022 – Swiss AR appointment deadline for Class IIb non-implantable/IIa devices**
    • 26 May 2022 – Second EUDAMED implementation date; postponed one additional year
    • 26 May 2022 – IVDR date of application, transition provisions apply***
    • 26 May 2022 – IVDR compliance mandatory for Class A non-sterile IVDs
    • 26 May 2022 – Switzerland-EU Mutual Recognition Agreement for IVDs ceases (non-Swiss companies require a Swiss AR and importer to market in Switzerland; Swiss manufacturers require an EU AR and EU Importer)**
    • 31 July 2022 – Swiss AR appointment deadline for Class I devices**
    • 31 July 2022 – Swiss importer must be identified on the device, its packaging, or in a document accompanying the device for MDD/AIMDD devices placed on the market in Switzerland
    • 25 October 2022 – MHRA announces the UKCA Marking deadline will be postponed; further, an additional transition period will be granted for CE Marked devices
    • 31 December 2022 – Swiss AR appointment deadline for Class D IVDs**
    • 2023 – Expected ‘go-live’ date for Swissdamed
    • 20 March 2023 – 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
    • 2023 – Expected ‘go-live’ date for Swissdamed
    • Q2 2023 – Third EUDAMED implementation date, postponed another year
    • 31 March 2023 – Class B and C IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland**
    • 26 May 2023 – UDI carrier required on labeling for MDR CE marked Class IIb and IIa devices and Class D IVDR labeling
    • 26 May 2023 – UDI direct marking required for MDR CE marked reusable Implantable and Class III devices
    • 1 July 2023 – Original expected publication date for new UKCA medical device regulations and UKCA Marking deadline, postponed two years  
    • 15 July 2023 – Expected implementation of new PMS requirements in Great Britain, to be followed by a six-month implementation period
    • 31 July 2023 – Swiss AR appointment deadline for Class A IVDs**
    • 1 September 2023 – New UK MHRA vigilance portal (MORE) must be used going forward – the old MORE portal is obsoleted
    • 1 January 2024 – Recommended date by when MDD/AIMDD legacy device manufacturers should request quotes from Notified Bodies
    • 26 May 2024 – MDD/AIMDD legacy device manufacturers must have meet the criteria established in Regulation 2023/607 to remain on the market
    • 26 September 2024 – MDD/AIMDD legacy device manufacturers must have a signed written agreement with a Notified Body to remain on the market
    • 31 March 2025 – Swiss AR must be identified on device labeling for professional use IVDs; allowance to provide AR info on a ‘document accompanying the device’ ends
    • 26 May 2025 – UDI carrier required on MDR Class I medical devices and IVDR Class B/C IVD labeling. Not applicable to MDD/IVDD legacy devices.26 May 2025 – UDI Direct Marking required for Class IIa and IIb reusable MDR devices. Not applicable to MDD legacy devices.
    • 26 May 2025 – 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.
    • 1 July 2025 – The date projected by the MHRA for the new UK medical device and IVD legislation to come into force in Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking.
    • 26 May 2026 –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.
    • 26 May 2026 – 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.
    • 26 May 2027 – UDI direct marking required for MDR reusable Class I devices. Not applicable to MDD legacy devices.
    • 26 May 2027 – UDI carrier required on labeling for IVDR CE marked Class A devices Not applicable to IVDD legacy devices.
    • 26 May 2027 – IVDR compliance date for Class A sterile and Class B IVDs.  IVDD legacy devices lawfully placed on the market prior to 26 May 2027 may continue to be supplied and put into service.31 December 2027 – MDR compliance date for Class III, IIb implantable devices. 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.
    • 30 June 2028 – MDD/AIMDD devices are no longer accepted in the UK. 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. Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking.
    • 31 December 2028 – MDR compliance date for Class IIb, IIa, I devices. MDD legacy devices are no longer recognized. To continue placing these devices on the market, they must be CE Marked to the MD
    • 30 June 2030 – Great Britain will no longer accept  CE marking.  The device must be UKCA Marked to continue being placed on the Great Britain market after this date. CE Marking, both under the Directives and Regulations, is no longer recognized in Great Britain (England, Scotland, Wales).   Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking.

 

*MDD Class I self-certified devices that were up-classed under the MDR are given a transition period to continue marketing under the MDD CE marking. Certain conditions apply. Class I sterile/measuring, IIa, IIb, and III/AIMD devices with valid MDD Notified Body issued CE Marking may continue marketing under the MDD until the CE Certificate expires or the transition period ends, whichever comes first. (MDR Article 120(3)). The original transition period was scheduled to end 24 May 2024; however, that was extended to 31 December 2027 for all Class III and for Class IIb implantable devices and to 31 December 2028 for all remaining devices.

**Once a manufacturer formally appoints a Swiss AR, the Swiss AR must appear on certain device documentation. The type of document depends on the class/type of device and EU conformity assessment leveraged: MDR Class I: labeling or document accompanying the device; MDR Class IIa, IIb, III: label; MDD: label, IFU or document accompanying the device; AIMDD: sales packaging and IFU or document accompanying the device; IVDR not intended for self-testing: labeling or document accompanying the device; IVDR for self-testing: label; IVDD: labeling, external packaging, IFU or document accompanying the device.

***Only 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 (IVDR Article 110). Certain conditions apply. Please see the rest of the timeline chart for the other IVDR compliance dates.

†CLICK HERE for more information defining ‘placing devices onto the market’.