Timeline – All Markets

Timeline – EU Only

Timeline – UK Only

Timeline – Switzerland Only

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’.