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  • 1.  RUO + CE marked devices = Meaning?

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    I understand that in the US, devices intended for research and investigational use must have an RUO disclaimer, while the EU does not require a CE mark for these devices. However, some devices clearly marketed only to research facilities and with prominent RUO disclaimers in the website, may be labeled with RUO and CE. Could you help clarifying:

    1- Does a CE mark in the EU specifically indicates diagnostic use, or may it be used as adherence to quality standards?

    2- Are there alternative ways to obtain a CE mark that do not imply diagnostic use?

    Thank you in advance!



  • 2.  RE: RUO + CE marked devices = Meaning?

    Posted 12 days ago

    Dear Anon

    CE Marking is explained at the following website. 

    "By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA."

    https://single-market-economy.ec.europa.eu/single-market/ce-marking_en

    Product Groups in which a CE Mark is available is presented here

    https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: RUO + CE marked devices = Meaning?

    Posted 12 days ago

    Hi Anon,

    CE-mark itself does not necessarily imply diagnostic use (e.g. non-IVD MD can be CE-marked) - it should be considered for what use the CE-mark has been authorized (refer to CE-marking certificate).

    CE-marking does imply compliance to the key requirements applicable in light of the device's characteristics and intended use (typically demonstrated by compliance to recognized standards)

    Kind regards,

    Clara



    ------------------------------
    Clara Desvignes
    Associate Director
    Voisins Consulting Life Science (France)
    Saint Grégoire
    France
    ------------------------------

    Original Message


  • 4.  RE: RUO + CE marked devices = Meaning?

    Posted 12 days ago

    Hello Anon,

    There was a similar question asked a few weeks ago which might help: https://connect.raps.org/discussion/ce-mark-for-ruo-device?hlmlt=VT.

    Labelling products as Research Use Only (RUO) can be challenging, because unfortunately some companies state this with their products to "get around" the regulations.  The device is still used in clinical application or reporting results, even though it is marked as RUO.  The CE Mark indicates conformity with the applicable Regulations which are then stated in the Declaration of Conformity.  A CE Mark does not indicate diagnostic use or adherence to a quality standard.  There is a lot more behind the CE Mark which must be understood.

    I am not sure understand the question if there are alternate ways to get CE Mark not indicating diagnostic use.  A CE Mark is applied for when a product is stating conformity to a Directive, i.e. no hazardous materials such as RoHS, or conformity to a Regulation, i.e. the EU IVDR.  Not implying diagnostic use of a product would not be CE Marked, probably as simple as that.  If the product is intended for research use only, then it is outside the scope of the Regulations.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 5.  RE: RUO + CE marked devices = Meaning?

    Posted 12 days ago

    Hello,

    I will add a clinical operations perspective to the discussion. 

    If you have a medical device that is used for research purpose you need to have a label stating that it is for research purposes. If the device has CE mark and you want to use it in clinical research you need to keep the CE mark and add a label to indicate that is for research purposes. 

    I had a client in the past that removed the CE mark from their device because they have made some very minor changes and wanted to use it in clinical research. The regulatory agencies then asked them to reinstate the CE mark.

    Good luck with you study.

    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


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