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  • 1.  Question on EU MDR745/2017 - Annex I Section: 23.2 Information on the label

    Posted 13-Jun-2018 14:41
    Hi,

    I have question on the on EU MDR 745/2017 - Annex I Section: 23.2 Information on the label.

    In this section the requirement is that "the label shall bear all of the following particulars" we have a total of 19 points that need to be added in the label.

    My question is whether the section 23.2 requirements is asking us to address all the requirements in the unit packaging label, shelf packaging label and pallet packaging labels ?
    Or if we could able to address the requirements in  any of these labels based on the available spaces in each of the labels !

    There is no specific details provided in MDR that whether where to place these contents or which label to be updated (Unit, Carton, shelf , packaging).

    The reason behind this question is we need to see a big quantum of work involved in doing the changes for all the packaging labels.

    Note: 
    Annex I Section 23.3 of MDR states that the requirements mentioned are to be updated in Sterile packaging, This is understood that on the unit packaging the contents mentioned in  the section 23.3 should be available.

    Please advise.






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    Vadivelan Dharanisingh
    Product Regulatoy Lead

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  • 2.  RE: Question on EU MDR745/2017 - Annex I Section: 23.2 Information on the label

    Posted 14-Jun-2018 01:43
    Vadivelan,

    My interpretation over the years has always been include all of the necessary information as available depending on space.  When you look at the different levels of packaging, these should include all the pertinent information to assure the device can be used safely and perform as intended.  I have been faced with situation where I had a unit size label, the label on the actual device packaging, or 1st level of packaging that literally was the size of half stick of gum.  The only information that I could physically put on the label was company name, lot number, and expiration date.  Then on my box container of 5 of the devices, this label was much larger that I could put all the applicable information that would be required under Annex I, Section 13 (MDD) and Annex I, Section 23 (MDR).

    Symbols make doing this alot easier so that there is not long lines of text to include, so make sure to look at ISO 15223.  At the same time, it has gotten more difficult because of UDI having to be there in AIDC format and human-readable format which can large a large amount of space even for a 2-D/Matrix size to make sure its readable.  My final thought and advice is address this as part of your risk management for those different levels of packaging and how they impact the safety and performance of the device.  So as an example, what is the risk that the actual device unit, 1st level of packaging, only have lot number and expiration date?  How does this impact the use?  What other risk controls have been implemented to make sure this risk is acceptable?  Go back to Annex I point 1 - 9 and link this to risk management that if you have to put limited information at lower levels of packaging, that the risk to the patient, user, etc. are as low as possible.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: Question on EU MDR745/2017 - Annex I Section: 23.2 Information on the label

    Posted 14-Jun-2018 04:43
    Hi Vadivelan,

    It may be worthwhile checking the MDR definition of 'label' from Article 2(13), which reads: 'label' means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

    So from this definition, as long as the information is on one or more of the device, primary pack, and secondary pack, the requirement in MDR Annex I Section: 23.2 will be met for non-sterile devices. This conclusion is echoed in MDR Annex I 23.1(b), although this paragraph requires the information to be on the device itself unless this is not practicable, when the information can be on the packaging.

    There are additional requirements for sterile packs, however, given, as you state, in MDR Annex I Section 23.3, and each of the listed requirements (a) to (j) must appear on the pack that provides the sterile barrier.

    You may be interested to know that ISO/TC 210/WG 3 is working on developing symbols for 10 of the new labeling requirements in the MDR that are not currently included in ISO 15223-1, these being:

    1. Medical Device
    2. Contains blood products
    3. Contains medicinal substance
    4. Contains CMR substances
    5. Contains Nano material
    6. Contains cell of Human Origin
    7. Contains Animal cells
    8. Sterilization by Vapour Phase
    9. Breaching compromises sterility
    10. Single Patient Use

    The current target for inclusion of these new symbols in ISO 15223-1 is the third quarter of 2019.

    There are at least another 10 symbols that will most likely need to be developed to cover all the new labeling requirements in the MDR, but these will probably not be included in ISO 15223-1 for at least 3-4 years.

    Hope this helps.



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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
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    Original Message


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