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  • 1.  EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    Dear community,

    My apologizes if the topic has already been discussed, but i could not found a clear response.

    EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

    Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

    or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

    Thanks in advance for your comments

    BR

    ik



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    iker mallabiabarrena
    Regulatory Affairs
    BD
    Eysin
    Switzerland
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  • 2.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    Hello Iker,

    Unfortunately, the EU MDR/IVDR are not precise in quite a few areas.  There are some who would read it as both and others reading as either/or.  Myself would use the commonality which has been performed by the industry for the last 50+ years and if there is a shelf life/expiration date, this would only be required.  If a shelf life or expiration date is used, the actual manufacturing date would not be necessary nor would it add any value to the labelling.  In fact, putting two dates on the sterile packaging might confuse the user.  If there is any clarification needed, a statement about the length of the shelf life could be made in the Instructions for Use (IFU) stating a "two year shelf life" which then a user could determine when the product was manufactured.  There may also be rare circumstances, based on risk of the device, where the shelf life and manufacture date would be included; this information should be included in the technical documentation as well as risk management describing why both would be needed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 3.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    Hi Iker and Richard,

    Instinctively (based on not yet 50 years experience) I would agree with Richard. Unfortunately, the MDR is rather clear.

    The following particulars shall appear on the sterile packaging:

    (h) the month and year of manufacture, 

    (i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month,

    The word "shall" is rather clear. Hence both must be included. And NB's are enforcing.

    (the only thing funny here is the month/year vs year/month - sorry, regulatory humor).



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    Robert van Boxtel
    Principal Consultant Medical Device Project B.V.
    MDProject
    Alphen a/d Rijn
    Netherlands
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  • 4.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    Hi Iker,

    I agree with Robert that in this case the MDR seems quite clear that both are mandatory (use of "shall", no "where applicable" and section (i) ends with "and").

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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  • 5.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    To further comment, yes it does say 'shall', but completely disagree with this approach since this is the only requirement in the world for this.  More and more every day liking FDA's "least burdensome approach" - adding regulatory hurdles and content which is not needed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 6.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    Don't we all!!

    Unfortunately, the regulators could care less about what we consider state of the art regarding these type of issues.

    On the other hand, there is a symbol for manufacturing date, so it is feasible to add both.



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    Robert van Boxtel
    Principal Consultant Medical Device Project B.V.
    MDProject
    Alphen a/d Rijn
    Netherlands
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  • 7.  RE: EU MDR labelling 23.3: Sterile packaging Information.

    Posted 9 days ago

    The safest compliance approach is to strictly observe section 23.3 and thus be sure that the sterile packaging includes both the month and year of manufacture along with the time limit for using or implanting the device safely.

    That said, if you are keenly intent on trying to avoid having both, then pose such approach to your Notified Body and/or Competent Authority.  In so doing, there are some substantive legislative bases on which to stand:

    • If EN ISO 20417 becomes harmonized with its current content which allows the sterile device label to include either the date by which it is safe to use or the date of manufacturer (for devices without a date by which it is safe to use), then that approach shall be allowed pursuant to Union MDR Article 8.

    • Regardless of harmonization status, EN ISO 20417 (as amended) is the generally acknowledged state of the art (notwithstanding questionable exploitation of the slithery discussion in MDCG 2021-5).  Proper consideration of the generally acknowledged state of the art is, and for decades has been, a preeminent requirement of European medical device legislation. Thus, I have a hard time believing or accepting the notion that regulators could care less about consideration of the generally acknowledged state of the art.  Indeed, to be so flippant would directly put the regulators out of compliance with the legislative requirements of the Union MDR.

    • Thus, regarding a device for which it is proposed that the expiry date rather than the manufacturing date would appear on the sterile packaging, Annex I(1) establishes that, taking into account the generally acknowledged state of the art [i.e., taking into account EN ISO 20417 (as amended) which doesn't require both dates], if the risk analysis shows that the device so labeled is safe and effective and doesn't compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, and that any risks which may be associated with its use when so labeled constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, then that should be a compelling basis for the Notified Body and/or Competent Authority to authorize such sterile packaging information.


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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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