Important Dates:
Europe, United Kingdom & Switzerland

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Important Dates – ALL

For the purpose of this Chart, “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 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 still accepted in the four UK countries until 2027-2029, depending on 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
  • 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 sold in Switzerland
  • 25 October 2022 – MHRA announces the UKCA Marking deadline will be postponed by one year; further, an additional 3-5 year 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
  • Q2 2023 – Third EUDAMED implementation date, postponed another year
  • 31 March 2023 – Swiss AR appointment deadline for Class C/B IVDs**
  • 26 May 2023 – UDI carrier required on labeling for MDR CE marked Class IIb/IIa devices
  • 26 May 2023 – UDI direct marking required for MDR CE marked reusable Implantable/Class III devices
  • 26 May 2023 – UDI carrier required on labeling for IVDR CE marked Class D devices
  • 1 July 2023 – Original expected publication date for new UKCA medical device regulations and UKCA Marking deadline, postponed one year   
  • 31 July 2023 – 31 July 2023 – Swiss AR appointment deadline for Class A IVDs**
  • Q2 2024 – EUDAMED scheduled to be fully operational, 6-24 month transition period starts
  • 26 May 2024 – MDD CE marked devices may no longer be placed onto the market in Europe and Switzerland
  • July 2024 – Expected implementation date for new UK medical device regulations; Great Britain to accept CE Marking for another 3-5 years based on type of device
  • Q4 2024 – Four EUDAMED modules (Actors, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance) scheduled to be mandatory in Europe and Northern Ireland
  • 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 – MDD CE marked device sell-off period ends in Europe and Switzerland
  • 26 May 2025 – UDI carrier required on labeling for MDR CE marked Class I devices
  • 26 May 2025 – UDI direct marking required for MDR CE marked reusable Class IIb/IIa devices
  • 26 May 2025 – IVDD Notified Body issued CE Certificates no longer recognized and sell-off period ends
  • 26 May 2025 – IVDD CE marked Class A non-sterile device sell-off period ends
  • 26 May 2025 – IVDR compliance date for Class D IVDs
  • 26 May 2025 – UDI carrier required on labeling for IVDR CE marked Class B and C devices
  • Q2 2026 – Final two EUDAMED modules (UDI/Devices and Notified Body Certificates) to be mandatory
  • 26 May 2026 – IVDR compliance date for Class C IVDs
  • 26 May 2026 – IVDD CE marked Class D device sell-off period ends
  • 2027 – Great Britain will no longer accept MDD CE marked devices (with valid CE marking certificate) and proof of MDR CE or UKCA marking must be provided instead; the exact month and day depends on the date the new UK Regulation goes into effect 
  • 26 May 2027 – UDI direct marking required for MDR CE marked reusable Class I devices
  • 26 May 2027 – IVDD CE marked Class C device sell-off period ends
  • 26 May 2027 – IVDR compliance date for Class A sterile and Class B IVDs, IVDD CE marking no longer recognized
  • 26 May 2027 – UDI carrier required on labeling for IVDR CE marked Class A devices
  • 26 May 2028 – IVDD CE marked Class A sterile and Class B device sell-off period ends
  • 2029 – Great Britain will no longer accept MDR/IVDR/IVDD CE marked devices and proof of UKCA marking must be provided instead; the exact month and day depends on the date the new UK Regulation goes into effect §

*MDD Class I self-certified devices which were up-classed under the MDR are given a transition period through 26 May 2024 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 26 May 2024, whichever comes first. (MDR Article 120(3))

**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’.

‡Some member states indicated they may continue to require notification for certain devices, irrespective of EUDAMED registration. 

§UKCA marking is required in Great Britain (England, Scotland, Wales) only. Northern Ireland, the fourth UK country, requires CE marking and does not recognize UKCA marking. Manufacturers may UKCA mark at any time. If companies opt to UKCA mark now, the device technical documentation must meet the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). The new MDR/IVDR-like regulations are not expected to go into effect until 2024. The UK Responsible Person is not required on labeling while devices are placed onto the UK leveraging European CE Marking.