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  • 1.  Personal Lubricant Classification in the EU

    Posted 06-Jul-2015 19:52
    I work for a personal lubricant company. We are attempting to expand to Europe, but if at all possible would like to get in as class I. Best I can tell, we become class II if the device (lubricant) is to be used longer than 60 seconds. Has anyone had experience with this? Any suggestions as to how to argue for class I? Anyone know of any lubricants that are class I in Europe? If we can't get class I, any suggestions on what clause to use? Thanks for the help!

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    Lauren Parker
    Valencia CA
    United States
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  • 2.  RE: Personal Lubricant Classification in the EU

    Posted 06-Jul-2015 20:15
    I've made the assumption this is a device under MDD. You need to verity that, since it might be a pharmaceutical in the EU.

    Presumably, you have competitors who market a similar product in the EU. Look at their CE Mark. If it doesn't have a four digit number, then a Notified Body was not involved, so it is probably Class I.

    Many companies post the Declaration of Conformity (DoC) on their web site. Often the DoC includes the classification rule from Annex IX. It may also be in the competitor's IFU.

    Lastly, there are no Class II devices in the MDD. What rule did you use to decide it is Class II?

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Personal Lubricant Classification in the EU

    Posted 07-Jul-2015 13:28

    Hi Lauren, Suggest you need to confirm if the lubricant falls within the definition of a "Medical Device"; a well defined Intended Use statement will assist and also enable the classification according to the MDD Annnex IX. Some questions for consideration: Sterility? Stability? Biocompatibility? Body part(s) to be lubricated? Is this intended to lubricate a medical device? Period of Exposure to tissue? The 60 secs seems rather odd for a change in EC classification!
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    George Buchan
    Managing Director
    G.P.B. Limited
    Prestwick KA9 1HP
    United Kingdom
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    Original Message


  • 4.  RE: Personal Lubricant Classification in the EU

    Posted 08-Jul-2015 09:00
    I think you mean 60 minutes.
    Art
    Note the MDD (which is close but not exactly the same as 10993) classifies based on:
    3.1.2.1. Duration
    Transient
    Normally intended for continuous use for less than 60 minutes.
    Short term
    Normally intended for continuous use for not more than 30 days.
    Long term
    Normally intended for continuous use for more than 30 days.

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    A Arthur Rankis
    President
    A. A. Rankis & Associates, Inc.
    Acton MA
    United States
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    Original Message