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  • 1.  Patient Implant Card -MDR Article 18

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2019 16:55
    This message was posted by a user wishing to remain anonymous

    Dear RAPS community

    Do someone have information on what should be the correct interpretation of MDR Article 18 (a) regarding lot number and serial number?

    Should be Lot number and serial number? Or, could be Lot number or serial number?

    Thank you for answers.


  • 2.  RE: Patient Implant Card -MDR Article 18

    Posted 21-Jun-2019 04:17
    Unfortunately there are a few places in the regulation where there are not clear logical operators or commas - leading to a lot of interpretation.  Personally I would read as Lot Number or Serial Number.  In all my years of experience I have never seen a finished medical device with a lot number and serial number.  There may be components inside or integrated as part of the finished medical device having serial numbers, i.e. a PCB board inside a medical device, but the finished medical device had either a lot number or serial number.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Patient Implant Card -MDR Article 18

    Posted 21-Jun-2019 21:35

    If the device has both a lot number then both need to be on the implant card. Anything in the list in Art. 18 that applies to the device needs to be on the implant card. Note that this includes the UDI. If the device has both a lot number and a serial number then both would be in the UDI and, when there is a UDI, included on the implant card.

    It would be strange if the UDI included both, but only one were on the implant card.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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