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  • 1.  Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    This message was posted by a user wishing to remain anonymous
    Posted 20-Sep-2019 09:34
    This message was posted by a user wishing to remain anonymous

    I want to independently verify CE Certificates issued by ISS but can't find a database on their website (www.is.it) and have had no response from emails sent to ISS.  Could anyone point me in the right direction?
    Thanks.


  • 2.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    Posted 22-Sep-2019 06:53
    There is no such database that exists currently - in the future this information will be available via EUDAMED.  I highly doubt ISS to provide you information verify CE Certificates issued by them - I have never had a Notified Body provide this information, in particular about another company.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    Posted 23-Sep-2019 02:32
    There are some Notifed Bodies that actually do list all companies that are certified like NSAI.  Here is the link for NSAI http://nsaiinc.com/company/files/ACL.pdf.  There could be others out there, I just happen to know about this one.  This list covers more than just the medical device certifications though, so you may need to sort through the list some to find what you need.

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



  • 4.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2019 09:25
    This message was posted by a user wishing to remain anonymous

    Thanks Leonard. It's really helpful when these databases are available but unfortunately ISS don't seem to have one available.


  • 5.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    Posted 23-Sep-2019 04:34
    Hi all,

    Yes some certificates can be verified directly on NB website or through IQnet or other kind of public ways.

    However, if not, from time to time, I contacted the notified body (of an external company) to verify if the submitted certificate (QMS and EC certificate) was valid and correct. I submitted them the received certificates and explained them the reason of required confirmation. And they instantly replied. Of course they may not provide an external certificate if you demand a copy of it but they can confirm its status. They are apparently kind of used to do that. This mainly for countries in Middle East (Bahrain if I am correct) that now want to have absolute certainty over the submitted certificates. To verify that there is no fraud...

    If this helps.

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    Maud Giorgi
    QMS & RA Manager
    Lausanne
    Switzerland
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  • 6.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    Posted 23-Sep-2019 07:07
    Actually it used to be a requirement.  Here is one example
    Search for a Certified Company
    Nsai remove preview
    Search for a Certified Company
    NSAI (National Standards Authority of Ireland) is Ireland's official standards body. We are the national certification authority for CE Marking and provide a certification service to enable business demonstrate that Irish goods and services conform to applicable standards
    View this on Nsai >


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    Beverly Whitaker
    Beaufort SC
    United States
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  • 7.  RE: Web or email address for verifying CE Certs issued by ISS (Notified Body 0373) in Italy?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2019 09:25
    This message was posted by a user wishing to remain anonymous

    Hi Richard. Some Notified Bodies do have databases online at their website (e.g. Kiwa, IMQ) or will respond to queries (e.g. BSI) but I haven't even had a response from the email addresses I could find on the ISS website.  EUDAMED should be much easier when it becomes available, but in the meantime, there is really no reason I can see that individual Notified Bodies would not provide confirmations.