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  • 1.  ISO 60601-X Standards

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2018 10:50
    This message was posted by a user wishing to remain anonymous

    Is it correct that a medical device that has a current 510(k) with an older version of a safety/emissions standard can continue selling the product in the US without testing to the current version?  It is understood that any new submissions will require testing to the current standard.

    I have found a reference that says that specific devices manufactured before a required implementation date may continue to be sold into Europe, and possibly other countries.  Is that true?  To clarify, if a device was manufactured on December 31, 2017 and the required date for the standard in Europe is Jan. 1, 2018 can that device be legally sold in Europe?

  • 2.  RE: ISO 60601-X Standards

    Posted 02-Jun-2018 02:44
    In Response to your questions about IEC 60601-1 related to US FDA Submissions.  If you tested under an older version of a standard when you submitted and the device has not changed or has not had significant changes, refer to Guidance documents on 510(k) Changes for medical devices and for software (2 documents), then you don't have a requirement to retest to the most recent standard.  Also, note if there have a been a lot of little changes you still may need a "Catch-up 510(k)" which is also covered in these Guidance documents mentioned above.  But once you do a significant change or have a catch 510(k) you will need to test to the updated standards.

    For Europe (under the EU MDD, AIMDD, & IVD) having manufactured a device is not the time that meets the 'Placing on the EU Market'.  Refer to the document located at this link for what the EU's interpretation of "Placing on the Market" means.  one part of the text of this document says "The interpretation of these terms indicates that the mere termination of the manufacture is not sufficient for a product to be placed on the market. In addition, it must have entered into the distribution chain.", but that is not sufficient so please read the whole document as there are quite a few subtleties in it.  So, I would roughly say when the device is at a location (like a warehouse or distribution point) where the device(s) have been sold to the organization purchasing them or similarly to that would be where the product needs to be located that you can have an older set of testing to be legally sold.  So, I do not agree with your statement about Europe.

    Hope this is helpful,

    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328

  • 3.  RE: ISO 60601-X Standards

    Posted 02-Jun-2018 03:32
    Agree with Leo in regard to Europe that just because your organisation received a CE Mark approval at some date in history, this does not preclude maintaining "state of the art" which is expected in Europe.  Therefore, whenever placing product on the market there is an expectation of conformity according to Annex I including state of the art.  While there are compliance dates for different editions of IEC 60601-x, you need to have an assessment, impact, risk, transition, quality plan, etc. for how your product goes from one version to the next.

    Richard Vincins RAC
    Vice President Regulatory Affairs