IVDR Round-Up: EU, Switzerland and UK
May 26, 2022
New MDCG Guidance: FAQs on the EU UDI System
June 10, 2022

Important Dates:
Europe, United Kingdom & Switzerland

Click here to see an overview of upcoming deadlines for medical devices and IVDs in the EU, UK and Switzerland

We recommend bookmarking this page. The Dates Chart is updated continuously, as new deadlines are announced or adjusted.

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 2026-2028, 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 AR required on labeling or document accompanying the device (MDR Class I) and on the label (MDR Class IIa, IIb, III) for products newly introduced to Swiss market; a transition period is available for MDR devices already on the market before this date
  • 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; must add Swiss AR to label (MDR); label, IFU or document accompanying the device (MDD); or sales packaging & IFU or document accompanying the device (AIMDD)
  • 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; must add Swiss AR to label (MDR); or label, IFU or document accompanying the device (MDD)
  • 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) 
  • 26 May 2022 – Swiss AR required on labeling or document accompanying the device (IVDR not for self-testing); on the labeling (IVDR self-testing); or label labeling, external packaging, instructions for use or in a document accompanying the device (IVDD) for products newly introduced to Swiss market; a transition period is available for MDR devices already on the market before this date 
  • 31 July 2022 – Swiss AR appointment deadline for Class I devices; must add Swiss AR to label (MDR); or label, IFU or document accompanying the device (MDD)
  • 31 July 2022 – Swiss importer must be identified on the device, its packaging or in a document accompanying the device for MDD devices
  • 31 December 2022 – Swiss AR appointment deadline for Class D IVDs; must add Swiss AR to labeling or document accompanying the device (IVDR not for self-testing); on the labeling (IVDR self-testing); or label labeling, external packaging, instructions for use or in a document accompanying the device (IVDD) 
  • Q2 2023 – EUDAMED scheduled to be fully operational, two-year transition period starts
  • 31 March 2022 – Swiss AR deadline for Class C and B IVDs
  • 26 November 2022 – Swiss registration deadline for IVDR CE marked devices which were already placed on the market before 26 May 2022
  • 31 March 2023 – Swiss AR appointment deadline for Class C/B IVDs; must add Swiss AR to labeling or document accompanying the device (IVDR not for self-testing); on the labeling (IVDR self-testing); or label labeling, external packaging, instructions for use or in a document accompanying the device (IVDD) 
  • 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 UKCA marking deadline; Great Britain to accept CE Marking for another 3-5 years, based on type of device  
  • 31 July 2023 – 31 July 2023 – Swiss AR appointment deadline for Class A IVDs; must add Swiss AR to labeling or document accompanying the device (IVDR not for self-testing); on the labeling (IVDR self-testing); or label labeling, external packaging, instructions for use or in a document accompanying the device (IVDD)
  • 26 May 2024 – MDD CE marked devices may no longer be placed onto the market in Europe and Switzerland***
  • Q2 2025 – EUDAMED scheduled to be mandatory in Europe and Northern Ireland; old registration process will be obsoleted
  • 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
  • 2026 – 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 2026 – IVDR compliance date for Class C IVDs
  • 26 May 2026 – IVDD CE marked Class D device sell-off period ends
  • 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
  • 2028 – 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
  • 26 May 2028 – IVDD CE marked Class A sterile and Class B device sell-off period ends

*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))

**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 2023. The UK Responsible Person is not required on labeling while devices are placed onto the UK leveraging European CE Marking.