Regulatory Open Forum

 View Only

  • 1.  Declaration of Conformity

    Posted 20-Jun-2018 11:53
    Hi Guys,

    I am working on a Medical Device System and need some guidance on the EU Declaration of Conformity. The below referenced NBRG document do provide a reference to the minimum content of DoC. However, I had the below questions:

    1. Should I mention the top-level system part number in the EU DoC or Should I include all the part numbers which belong to the system in the EU DoC? What is required as per regulation?
    2. For Global registrations - specifically the Asian markets - has anyone experienced any requirement of listing all the part numbers in the DoC? Is it recommended to include all the part numbers in the DoC to avoid importation/registration issues globally? 
    3. Every part number which is CE marked as a part of a system (whether it has the notified body number or is CE marked as such) needs to be on the DoC - Is my understanding correct?

    Any guidance is highly appreciated.

    Best regards,

     

    http://www.meddev.info/_documents/NBRG_ConsensusStatements0403-ver01-2003.pdf
    Meddev remove preview
    View this on Meddev >
    http://www.meddev.info/_documents/NBRG_ConsensusStatements0403-ver01-2003.pdf -
    Meddev remove preview
    View this on Meddev >


    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------


  • 2.  RE: Declaration of Conformity

    Posted 21-Jun-2018 16:30
    Hello,

    Just following up on my queries mentioned above. Any guidance will be highly appreciated.

    Best regards,

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Declaration of Conformity

    Posted 22-Jun-2018 03:48
    ​Hi Meenakshi
    the DoC is a document where the legal entity responsible for the CE marking of products declares that the products meet the requirements of the applicable directives. If your products are active devices (non-implantable), they will need to also conform to the requirements of ROHS, and if they use radiofrequency telecomunication (e.g. for RFID) they will also need to comply to the RED regulation. The DoC will need to declare conformity to all applicable regulations. Therefore, if you have an active medical device the DoC will list both 93/42/EEC and 2011/65/EU (and you will have a Technical file for both regulations).

    The DoC applies to finished products that are intended to be placed on the EU market. Spare parts and components are not finished products and as such should not be listed on the DoC. Any finished product that is placed on the marked with it own REF should be listed, regardless if a Notified Body was involved in the CE marking or not. In the end your Technical Files and your DoC should by aligned and list the same products.


    Hope this hleps

    Andrea

    ------------------------------
    Andrea Sparti
    Regulatory Affairs Manager
    Bienne
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: Declaration of Conformity

    Posted 22-Jun-2018 09:39
    Hi Andrea,

    Thanks so much! It certainly helps:) Two more questions:

    1. I understand Spare Parts. However, not components. How do we define components? 
    2. Any Finished product that is placed on the market with its own REF should be listed, regardless if a Notified Body was involved in the CE marking or not. - All these Finished products must be CE marked. Right?

    Best regards,
    Meenakshi

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 5.  RE: Declaration of Conformity

    Posted 22-Jun-2018 04:13
    Hi, 

    in addition to the good comment from Andrea, two aspects from me:
    - is your system composed of products which are medical devices in their own right? Than they need their own DoCs.
    - Do you have a mix of Class I and higher classes? Than you might need separate DoCs, as the information about the notified body is not required / mandated for class I DoC's

    ------------------------------
    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
    ------------------------------

    Original Message


  • 6.  RE: Declaration of Conformity

    Posted 22-Jun-2018 10:12
    Hi Uwe,

    Thanks for your guidance. It is very helpful!

    - The system is composed of class IIa, IIb and class I devices and also products like customized cables (which are specific for the system so I am assuming they are accessories). The products are medical devices, however, can only function as a system. They can't work individually. Do they still need to have their own DoCs?


    - Yes, it's a mix of class I devices and higher class (IIb) devices, however, don't the class I devices gets the system classification (IIb)? Should I have a separate DoC for class I devices and not put class I devices in our System DoC?

    I appreciate your kind guidance. Is there any particular guidance document which details these concepts of EU DoC which I am missing?

    Have a good day ahead!

    Best regards,
    Meenakshi

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


Related Content