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  • 1.  CE Mark on an inhaler

    This message was posted by a user wishing to remain anonymous
    Posted 06-May-2021 15:12
    This message was posted by a user wishing to remain anonymous

    Greetings everyone,

    I am still new to regulatory and have a question that I hope can be answered.

    Does a CE mark have to be placed on an inhaler itself?

    Thank you for your help as I continue to learn more about EU.



  • 2.  RE: CE Mark on an inhaler

    Posted 07-May-2021 02:04
    In Europe the term "combination product" is not defined (as e.g. in the US). Inhalers (e.g.) are either regulated as medical devices (to be CE marked) or as medicinal products (NOT to be CE marked). 

    MDR Article 1 (9) defines the following: Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.

    However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned. 

    There are still some discussions regarding what means "single integral"  but in most cases it is clear.Regarding your inhaler this means the following:

    1)  If the inhaler and the drug product are sold separately (that's the case normally when the inhaler is reused), then this is regulated as a medical device and needs to be CE marked
    2) If the drug and the inhaler form a single (integral) unit and the inhaler is disposable, then the whole product is regulated as a medicinal product. However, as per Article 117 of the MDR you will need to obtain an opinion of a Notified Body (designated for such products) on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I of the MDR.

    While this is very important from a regulatory perspective it doesn't matter a lot for design & development folks because regardless of how the device is regulated, it needs to conform with the relevant general safety and performance requirements (GSPR).

    Hope this helps, otherwise please let me know.

    Cheers, Beat


    ------------------------------
    Beat U. Steffen
    Founder & CEO
    confinis ag
    Sursee, 6210
    Switzerland
    www.confinis.com
    ------------------------------

    Original Message


  • 3.  RE: CE Mark on an inhaler

    Posted 07-May-2021 02:12
    Hello Anon,

    A inhaler device could be purely a medical device, if for example used for different applications or different drugs, or could be considered an integrated unit if say single-patient disposable.  Beat provided good information about combination products not defined in the EU regulation, sadly - it is either a medical device or it is a drug product.  This depends on primary mode of action and how the device/drug is "combined".  Absolutely important that now under the EU MDR, regardless if a single integrated unit the device component would need to comply with the General Safety and Performance Requirements (GSPR) from Annex I of the regulation.

    ------------------------------
    Richard Vincins RAC
    ------------------------------

    Original Message


  • 4.  RE: CE Mark on an inhaler

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2021 16:04
    This message was posted by a user wishing to remain anonymous

    Is it laziness? or efficiency?

    Sometimes, if I don't have time to research a labelling question properly, I just do an image search of the competitor product's labelling. It doesn't work every time, but often it will give a quick answer.

    Don't tell anyone my secret! ;)
    Original Message


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