Several critical regulatory deadlines are approaching in May 2025 that manufacturers of medical devices and in vitro diagnostic devices (IVDs) should be aware of:
UDI Labelling Requirement
By 26 May 2025, manufacturers of Class I (MDR) and Class B & Class C (IVDR) devices must ensure that the UDI carrier is affixed to the device label, in accordance with the relevant provisions under the MDR and IVDR. In addition, manufacturers of Class IIa & IIb Reusable devices must ensure that the UDI is directly marked on the device.
Quality Management System (QMS) Implementation for IVDR Transition
Manufacturers intending to benefit from the extended transitional provisions under the IVDR must have a QMS implemented in line with Article 10(8) of the IVDR by 26 May 2025. This is a prerequisite for continued market access during the transition period.
Class D IVD Conformity Assessment Applications
Also, by 26 May 2025, manufacturers of Class D IVDs are required to submit a formal application to a Notified Body for the conformity assessment of their devices under the IVDR framework.
Table of Important Dates
The table below shows the dates mentioned above, as well as some other deadlines approaching in September
| Month | Date | Urgency | Description of Action to be taken by Manufacturer |
| May | 26th May 2025 | High | Deadline for manufacturers of the following devices to ensure that the UDI carrier is correctly affixed to the device, label or packaging. Class I Medical Devices Class IIa & IIb reusable devices (direct marking) Class B & Class C IVD devices |
| 26th May 2025 | High | Deadline for Class D IVD Manufacturers to Submit a Conformity Assessment Application to a Notified Body Under the IVDR to Qualify for the Transition Period Extension. | |
| 26th May 2025 | High | Deadline for IVD Manufacturers of all Classification to Implement a QMS in accordance with Article 10(8) of the IVDR to Qualify for the Transition Period Extension. | |
| September | 26th September 2025 | Medium | Deadline for Class D IVD Manufacturers to have a signed agreement with the notified body in place |
| 26th September 2025 | Medium | Deadline for Notified Body who issued CE Certificate under the IVDD to sign agreement with respect to the surveillance of device |
