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  • 1.  CE mark - accessory

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2023 09:05
    This message was posted by a user wishing to remain anonymous

    Dear RAPS community,

    The question about accessories for medical devices under MDR- does the accessory require the CE mark / self-declaration? 

    Thank you for the clarification!

  • 2.  RE: CE mark - accessory

    Posted 25-Oct-2023 10:21

    If a product meets the definition of an "accessory for a medical device" [Union MDR Article 2(2)], then the Union MDR requirements applicable to a "[medical] device" [Article 2(1)] also apply to an accessory. This includes, but is not limited to, creating a DoC and affixing the CE mark just like what would be done for a device.

    To decide upon an appropriate conformity assessment route for the accessory, we are required to apply the same conformity assessment procedures [Article 52] as we would apply for a medical device.  To do this, first remember Annex VIII.3.2 which requires that accessories shall be classified in their own right separately from the device with which they are used.  Once the appropriate class is determined for the accessory, then return to Article 52 to identify a conformity assessment route based on the class.  Depending on class, the conformity assessment route will involve either self-declaration or else involvement of a Notified Body.

    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

  • 3.  RE: CE mark - accessory

    Posted 25-Oct-2023 10:54

    Hi Anon,

    one additional point: Article 1(4) states that

    "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

    In consequence, any requirement in the MDR that addresses "devices" includes accessories and Annex XVI products as well (as e.g. Articles 19 and 20 that deal with DoC and CE-marking do).

    Best regards,


    Christoph Kiesselbach