MDR and IVDR deadlines by class

End of the transitional period

Date after which a legacy device can no longer be placed on the market or put into service without a certificate issued under the new regulation. A class I device that did not require a notified body under the directive has no transitional period: it had to comply with the MDR from 26 May 2021.

Conditions to remain under the transitional period

The transitional period is conditional. Three dated milestones per class; missing one forfeits the right to place the device on the market. Substantive conditions apply as well: the device must still comply with the directive, without significant changes in design or intended purpose, and with post-market surveillance and vigilance compliant with the new regulation.

UDI carrier on the label

All these dates have passed, except IVD class A. For reusable devices whose carrier must be placed on the device itself, the obligation applies two years after the date of the class.

Serious incident reporting timelines

The period runs from the day the manufacturer becomes aware of the incident. An initial incomplete report is allowed and must be completed afterwards.

Registration and updates

What about Switzerland?

The MedDO and the IvDO adopt the same end-of-transition and UDI carrier dates as the MDR and IVDR. Obligations specific to Switzerland — authorised representative, Swissmedic registration, CHRN — are detailed in the Switzerland and EU-and-Switzerland pathways: Roadmaps by market and class

FAQ

What is the MDR deadline for a class IIa device under a directive certificate?

31 December 2028, provided an application was lodged with a notified body before 26 May 2024 and a written agreement was signed before 26 September 2024 (Regulation (EU) 2023/607, MDR Article 120(3c)).

Does a class I device have a transitional period?

Only if it requires a notified body under the MDR while it did not under the directive: sterile devices, devices with a measuring function, reusable surgical instruments, up-classified devices. It then runs to 31 December 2028. A class I device self-certified under both the directive and the MDR had to comply from 26 May 2021.

What are the IVDR transition dates?

31 December 2027 for class D, 31 December 2028 for class C, 31 December 2029 for classes B and A sterile, subject to a quality management system in place by 26 May 2025, then an application lodged and an agreement signed with a notified body by the dates specific to each class (Regulation (EU) 2024/1860).

How quickly must a serious incident be reported?

15 days as a general rule, 10 days in the event of death or an unanticipated serious deterioration in health, 2 days in the event of a serious public health threat, counted from the day the manufacturer becomes aware of it (MDR Article 87(3) to (5); IVDR Article 82).