Regulatory Open Forum

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  • 1.  Definition of variant, generation, configuration, combination in MDR

    Posted 03-Apr-2022 10:31
    Dear All,

    What can be the clear determination of definitions above at the level of the technical composition/difference of the medical device and the related technical file document?

    Can be applied the "variant" if the CE-marked device is planned to register and place in another, non-EU country? Another country has special requirements for labeling to be contained additional unique information.

    Thank you very much all for your valuable comments in advance.

    Best regards,

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    Aniko Bertok
    Head of Quality Management
    Oncotherm Kft.
    Hungary
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  • 2.  RE: Definition of variant, generation, configuration, combination in MDR

    Posted 04-Apr-2022 04:18
    Good day Aniko,

    There is not really definitions of those terms in the EU MDR and I think you would be hard pressed to find them in other regulations.  Probably the most explicit place of variants is Health Canada in some of their guidance.  It would probably be advantageous to define these within your own technical documentation especially "previous generation of device" because this can be varied between different products.  When discussion variants, versions, models, or even part numbers, it might be better to have these defined in the company.  I am not sure following your question about applying a variant of CE Marked to another non-EU country.  Assuming you mean having a EU version or a US version - many companies would have different part numbers and different labelling for the different versions.  Also companies have a single version, single labelling for products which are sold in multiple countries.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Definition of variant, generation, configuration, combination in MDR

    Posted 04-Apr-2022 05:27
    Dear Richard,

    Thank you for your valuable response. I see, would let the MDR variant questions go then.

    It is a tricky situation, because, for .e.g Mexico wants to get a CE-marked medical device.
    But the label information should be added e.g. registration number after the registration process.
    Many countries, outside the EU, think like this. They require a CE-marked (EU) device as the basis, and they want to see additional information on the device(label).
    So, the approved (by the EU notified body) product and product label should have such kind of information which is not subject to the technical assessment by the EU NB - because the manufacturer did not ask the NB for this task. And there are no requirements from the side of the country because their basic requirement is a valid EU CE assessment only.
    I hope our thoughts are clear.
    How can be managed these "different products" well? From the manufacturer's side and aspect of the EU NB?

    Thank you for your comments in advance.

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    Aniko Bertok
    Budaörs
    Hungary
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  • 4.  RE: Definition of variant, generation, configuration, combination in MDR

    Posted 05-Apr-2022 05:04
    Aniko,

    It is a tricky situation indeed and really depends on the view or approach of the Notified Body regarding other information contained on the labelling.  There are two aspects which probably can not be answered by a post is the actually labelling you are speaking about and the approach your Notified Body would take.  It might be good to have a candid conversation with your Notified Body on content of the label.  This might dictate whether you need to have different products/part numbers in order to have different labelling for shipping in different countries.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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