Mandatory UDI Deadlines for Medical Devices
26th May 2021 is the day when the Medical Device Regulation (MDR) comes into full force to be followed one year later by the In-Vitro Diagnostic Regulation (IVDR) on 26 May 2022. Both of these regulations have a mandatory obligation for UDI assessment and compliance.
With the incoming MDR, regulatory compliance is even more stringent. As we all know, MDR places much greater emphasis on safety and traceability. UDI is an addition to the traceability function, and all Medical Devices should submit the UDI data in the EUDAMED database within the following schedule
- 26th November 2022 – Medical Devices
- 26th November 2022 – In Vitro Medical Devices
(provided that EUDAMED is fully functional before the date of application of the respective Regulation; otherwise, this obligation applies 24 months after EUDAMED has become fully functional)
Manufacturers have the flexibility to voluntarily comply with the requirements starting from 26th May 2021 for Medical Devices and 26th May 2022 for In Vitro Medical Devices.
The MDCG 2019-4 guidance document provides more information about the EUDAMED registration process.
The obligation for placing the UDI carrier applies according to the following timelines:
MDR Placing UDI-carriers on the labels of devices (MDR Article 123(3)(f), Article 27(4)):
- Implantable and Class III devices - 26th May 2021
- Class IIa and Class IIb devices - 26th May 2023
- Class I devices - 26th May 2025
Direct marking of the reusable devices (MDR Article 123(3)(g), Article 27(4)):
- Implantable and Class III devices - 26th May 2023
- Class IIa and Class IIb devices - 26th May 2025
- Class I devices - 26th May 2027
IVDR Placing UDI-carriers on the labels of devices (IVDR Article 113(3)(e), Article 24(4)):
- Class D IVDs - 26th May 2023
- Class C and B IVDs - 26th May 2025
- Class A IVDs - 26th May 2027
That’s a lot of different critical dates to remember, especially if your product portfolio contains several different classes of medical devices and diagnostics!
Do not worry; our experts at Med-Di-Dia are here to help, guide and support.
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