What are the highlights?
The guidance document confirms the transition dates and outlines which sections of the IVDR do and do not apply to legacy devices.
Last date by which legacy IVDs may be placed onto the market
- Notified Body issued IVDD CE marking certificates – 26 May 2025
- 26 May 2025 – Class D
- 26 May 2026 – Class C
- 26 May 2027 – Class B & Class A Sterile
For example, if your IVD was previously self-certified under the In Vitro Diagnostics Directive (IVDD) 98/79/EC, but is now Class C under the IVDR, you may continue to place the IVDD CE marked device onto the European market until 16 May 2026. Any products placed onto the market after this date, must have IVDR CE marking.
Conditions apply. For more information, please read: What are Legacy Devices?
For more information on deadlines, please read: Placing on the Market – Definition and Cutoff Dates
Last date by which legacy IVDs may be put into service (i.e., sell-off date)
- Notified Body issued IVDD CE marking certificates – 26 May 2025
- 26 May 2026 – Class D
- 26 May 2027 – Class C
- 26 May 2028 – Class B & Class A Sterile
What is the impact of the IVDR on ‘old’ devices?
Old IVD devices are those that were placed on the market or put into service before 26 May 2022. Old devices are already in the European distribution chain, or with the end user, before the IVDR’s date of application.
The MDCG guidance states that the IVDR is generally not applicable to old devices. However, some aspects do apply.
Specifically, IVDR market surveillance activities may apply to old devices. The reason is because:
“This allows competent authorities to check that those devices are in conformity with the rules applicable at the moment when they were placed on the market and to take appropriate measures against non-compliant or unsafe devices.”
Further, reporting and analysis of serious incidents and field safety corrective actions that occur after 26 May 2022, should be done in accordance with the IVDR (Art. 82 & Art. 84).
Applicable IVDR Sections
The below table is not comprehensive. We recommend reviewing the Annex (page 8) of MDCG 2022-8 to confirm the full table of items.