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  • 1.  EU MDR nanomaterials requirements

    This message was posted by a user wishing to remain anonymous
    Posted 02-Mar-2020 09:10
    This message was posted by a user wishing to remain anonymous

    ​Hello Everyone,

    Under the new EU MDR we require to have requirements defined around nanomaterials. The REACH guidance was updated last year which took effect in Jan,2020 this year. It states that the nanomaterials are covered under "substances". Can we just add a rationale mentioning that REACH document covers "nanomaterials" under "Substances" or do we still need a separate document from our supplier that describes nanomaterial specifically?

    Any advice/opinion is appreciated!


    Thanks!


  • 2.  RE: EU MDR nanomaterials requirements

    Posted 03-Mar-2020 02:16
    Hi Anon,

    The first step is to address the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body.
    This is usually performed in the design phase of the device.
    In my opinion, the assessor will expect to see the full material and chemical characterization of the device and the nanomaterials will be one of the critical materials, as stated by the MDR.
    Furthermore, in order for you to classify correctly the device with Rule 19, you have to prove in details the level of internal exposure to the patient. That requires a lot of data and information from the supplier and probably a lot of work from your side, to clarify the exposure.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 3.  RE: EU MDR nanomaterials requirements

    Posted 03-Mar-2020 14:45
    Agree with what Spyros said ... and to add look at Annex I of the EU MDR: GSPR.  If you go through the GSPR properly, it should help you to fully document the materials, substances, etc. used of your nanomaterials.  These should also be linked to your risk management file following on what Spyros was discussing regarding exposure, absorption, etc.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: EU MDR nanomaterials requirements

    This message was posted by a user wishing to remain anonymous
    Posted 04-Mar-2020 11:08
    This message was posted by a user wishing to remain anonymous

    ​Thank you Spyros and Richard.
    As you mentioned, in order to classify correctly the device with Rule 19, you have to prove in details the level of internal exposure to the patient. What level of details is expected in Classification document?
    When Classifying our device, we need to add a justification as to why a Rule applies or does not apply. Do we need to provide evidence or reference documents while classifying or we can simply refer to "Rule 19 - XX device does not incorporate or consist of nanomaterials" and then have it documented in risk management file and reference the RMF file in GSPR as well?

    Thanks again!
    Original Message


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