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  • 1.  MDD Non-Sterile vs sterile CE marking/labeling

    Posted 03-Nov-2015 08:47

    Hi,

     

    Does anyone know if there are specific rules for CE marking/labeling and documentation (i.e. DOC) for EU non-sterile products versus sterile products for class IIa or higher? My understanding is that a non-sterile class 1 may have a CE mark without a notified body number, but requires Instructions for use on sterilization ( I cannot find support documentation for this, it is what I have been told). What if the product is a bulk non-sterile, class IIa meant for a kit packer and not the end customer? I am being asked by Saudi to produce a DoC for registration for this bulk, non-sterile class IIa.

     

    Thank you,

     

    Denise L Hebert, COT, RAC
    Regulatory & Medical Manager
    Waltham, MA

     



  • 2.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 04-Nov-2015 10:35

    Hi Denise,

    The headpoint for regulation of MDs in Europe is the MDD 93/42 and subsequent amendments. This regulation lays out special requirements for labelling sterile products (both on the product label, packaging and the instruction for use): refer Annex A, Essential Requirement 13.3 and 13.6.

    Also, sterile vs non-sterile makes some difference in the conformity assessment procedure manufacturers must follow to apply the CE mark. As part of such differences, the technical file and manufacturing controls have special requirements.

    Kind regards,

    Lorenzo

    ------------------------------
    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom

    Original Message


  • 3.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 05-Nov-2015 08:00

    Hi Denise,

    A lot more information would be need to figure out the answers to your situation, but a few quickies are:

    > special requirements for sterile … yes, too many for describing here.

    > NB involvement? … absolutely yes for all sterile devices

    > bulk product requirements … lots of factors, starting with …is the product a device, accessory, or a component?

    Best –

    Art Rankis

     




    Original Message


  • 4.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 05-Nov-2015 12:11

    Thank you all for your comments. It is a medical device that is bulk non-sterile. We have been asked by Saudi for a DoC and that is how the discussion got started internally at my office and hence my reaching out for further guidance. My understanding is a MDD Class I non-sterile may have a self-declaration (no NB involvement), but what if it is a MDD Class IIa? (still bulk, non-sterile device)?

    Regards,

    Denise

    ------------------------------
    Denise Hebert RAC
    Regulatory / Medical Manager
    Beaver-Visitec International, Inc (BVI)
    Waltham MA
    United States

    Original Message


  • 5.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 05-Nov-2015 18:09

    Denise,

    Regardless of sterility, a Class IIa product would have an EC Certification from a NB and you would have a D of C associated with the product. The CE Mark would also have the NB reference.

    Is this what you are trying to confirm?

    ------------------------------
    James Leong
    Iowa City IA
    United States

    Original Message


  • 6.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 06-Nov-2015 08:21

    Hi James,

    Yes, thank you. The class IIa was an additional question. Originally, I wanted to know if a non-sterile MDD Class I could have a self-declaration DoC (I believe the answer to this is yes). Shall the Class I non-sterile have the CE mark without NB number?

    Thanks to all.

    Regards,

    Denise

    ------------------------------
    Denise Hebert RAC
    Regulatory / Medical Manager
    Beaver-Visitec International, Inc (BVI)
    Waltham MA
    United States

    Original Message


  • 7.  RE: MDD Non-Sterile vs sterile CE marking/labeling

    Posted 05-Nov-2015 08:23
    Denise,

    You've got great info from others.

    From my part, I would refer you to Summary Technical Documentation (STED) for medical devices.

    I discuss all the details on my seminar below. 


    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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    Original Message