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  • 1.  , Compliance and Scope of CE marking for 2 independent systems

    Posted 25-Jul-2019 07:28

    Hi,

     

    If we have a product (A) manufactured and CE marked by us , product (B) manufactured by the third party and CE marked by them– These are 2 independent systems, however  to be shipped together , to be kept on a same table, to be powered by the same PSU , does this become one system ?The systems have been independently tested for EMC and electrical safety .Would the 2 systems need to be again tested together  for EMC ?,

    If yes , then does that invalidate the CE marking of the product (B) and does that mean we become the manufacturer of this system too?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     





  • 2.  RE: , Compliance and Scope of CE marking for 2 independent systems

    Posted 26-Jul-2019 03:46
    Yes, Rashmi, this becomes a 'system' according the IEC 60601-1, and it also becomes an Article 12 system under the MDD (Article 22 under the MDR).

    You will need to assess compliance of the system for safety and EMC in accordance with IEC 60601, and you will become the 'assembler' of the system for European regulatory compliance purposes, so must follow the Article 12/22 requirements before placing the system on the European market. The system assembler takes on certain responsibilities akin to those of the manufacturer, but the system itself does not require a new CE mark.

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

    Original Message


  • 3.  RE: , Compliance and Scope of CE marking for 2 independent systems

    Posted 28-Jul-2019 01:46

    Hi Roger,

     

    Thanks for your inputs, it's been extremely useful. However would you be able to tell me if this has any impact on our QMS certification?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 4.  RE: , Compliance and Scope of CE marking for 2 independent systems

    Posted 28-Jul-2019 08:10
    Hi Rashmi, 

    You should certainly have documented procedures to ensure compliance with MDD Article 12, however there is no requirement for your MDD Annex II/V Notified Body to be involved in your 'assembler procedures', but if you want 'system assembly' to be part of your ISO 13485 certificate scope, then these procedures may be included within the certification body audit.

    Roger

    -------------------------------------------------------------------
    Roger Gray
    VP Quality and Regulatory
    DONAWA LIFESCIENCE CONSULTING
    Clinical Studies - Regulatory - Quality Systems
    Piazza Albania 10, 00153 Rome, Italy
    Tel: +39 06 578 2665 - Fax +39 06 574 3786
    Cell: +44 7795 226212 - UK Office: +44 1425 489208
    Skype: Roger.Gray48
    VISIT www.donawa.com FOR
    REGULATORY RESOURCES AND ARTICLES


    CONFIDENTIALITY NOTICE: The materials in this electronic mail transmission, including all attachments, are private and confidential and are the property of the sender. If you have received this email message in error, please notify the sender immediately by telephone at +39 06 578 2665 or by email to sara@donawa.com and thereafter, please destroy the message immediately. Thank you.




    Original Message


  • 5.  RE: , Compliance and Scope of CE marking for 2 independent systems

    Posted 28-Jul-2019 20:33

    Hi Roger ,

     

    Thanks again, is this option mentioned in the MDD/MDR?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 6.  RE: , Compliance and Scope of CE marking for 2 independent systems

    Posted 29-Jul-2019 04:24
    Do you mean the option to include 'assembly' in your ISO 13485 scope? If so, then no, this is not mentioned in the MDD/MDR, because the MDD/MDR do not require ISO 13485 certification. Certification to ISO 13485 is voluntary, and the scope of your ISO 13485 certificate can be different from your MDD Annex II/V scope.
    .

    Roger

    -------------------------------------------------------------------
    Roger Gray
    VP Quality and Regulatory
    DONAWA LIFESCIENCE CONSULTING
    Clinical Studies - Regulatory - Quality Systems
    Piazza Albania 10, 00153 Rome, Italy
    Tel: +39 06 578 2665 - Fax +39 06 574 3786
    Cell: +44 7795 226212 - UK Office: +44 1425 489208
    Skype: Roger.Gray48
    VISIT www.donawa.com FOR
    REGULATORY RESOURCES AND ARTICLES


    CONFIDENTIALITY NOTICE: The materials in this electronic mail transmission, including all attachments, are private and confidential and are the property of the sender. If you have received this email message in error, please notify the sender immediately by telephone at +39 06 578 2665 or by email to sara@donawa.com and thereafter, please destroy the message immediately. Thank you.




    Original Message


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