Hi Arslan
If you're looking at the Canada MDR, section 21 says the label shall contain the expiry date of the device, if the device has one.
If you're looking at the EU MDR, Annex I, section 23.2 says where there is no expiration date the label shall contain the date of manufacture.
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Anne LeBlanc
United States
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Original Message:
Sent: 24-Apr-2023 07:01
From: Ronald Boumans
Subject: Manufacturing Date - Class I Devices
See Annex VI, section 3.5: If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.
If you use the serial number on the device, this would allow for adequate traceability and you only need to add the serial number to the UDI-PI.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 23-Apr-2023 14:31
From: Arslan Rahat
Subject: Manufacturing Date - Class I Devices
Any documented confirmation that if class 1 reusable Medical Devices such as wheel chair require the manufacturer date on product itself or would the serial number be sufficient traceability for MDR? Or do we need both?
What should required on product itself?
And what required on packaging label?
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Arslan Rahat
QA Manager
Toronto ON
Canada
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