研讨会和活动
Deadlines
The obligation for UDI assignment: it applies as from the date of application of the two new Regulations, i.e. 26 May 2021 for medical devices (MDR) and 26 May 2022 for in vitro diagnostic medical devices (IVDR).
The obligation for submission of UDI data in the EUDAMED database: this obligation applies 24 months after EUDAMED has become fully functional.
The obligation for placing the UDI carrier applies according to the following timelines:
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MDR Placing UDI-carriers on the labels of devices (MDR Article 123(3)(f), Article 27(4)):
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Implantable and class III devices: 26 May 2021
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Class IIa and class IIb devices: 26 May 2023
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Class I devices: 26 May 2025
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Direct marking of the reusable devices (MDR Article 123(3)(g), Article 27(4)):
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Implantable and class III devices: 26 May 2023
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Class IIa and class IIb devices: 26 May 2025
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Class I devices: 26 May 2027
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IVDR Placing UDI-carriers on the labels of devices (IVDR Article 113(3)(e), Article 24(4)):
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Class D IVDs: 26 May 2023
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Class C and B IVDs: 26 May 2025
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Class A IVDs: 26 May 2027
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The following videos may also assist.