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  • 1.  Freedom of Information - CE Marking

    Posted 23-Dec-2019 08:41
    Hi All.

    Happy Christmas!

    Does anyone know how the FOI works in relation to CE Marking? I am guessing this would work in the same way as the FDA in regards to a FOI request is made and the NB then contact you to provide a redacted copy of your Technical File?

    Thanks in advance.

    James

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    James
    Head of QARA
    UK
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  • 2.  RE: Freedom of Information - CE Marking

    Posted 23-Dec-2019 10:36
    Edited by Julie Omohundro 23-Dec-2019 11:28
    "FOI" refers to the Freedom of Information (FOI) Act, which is part of US law.  I'm pretty sure the EU, which is not big on transparency, does not have anything like it.  Even if it did, notified bodies are private-sector companies, not branches of government, so legal authority would probably have a harder time reaching that far..

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 04:26
    Hi James,

    I suspect it wouldn't work like that. As a private company I doubt the notified body could be subject to an FOI request. It would be the MHRA (or equivalent) that would receive the FOI request. But given an NB would not decline any request for info. from their CA, if a concern, you should ensure your contract with your NB allows you to restrict the further distribution of commercially confidential information.

    Kevin

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    Kevin Painter
    Bournemouth
    United Kingdom
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    Original Message


  • 4.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 04:39
    There is no Freedom of Information for CE Marking, and certainly not from Notified Bodies as these are private contracts with companies.  There are individual countries like UK and Belgium that have freedom of information type of process, but it would need to be handled in the local language and not many of them are easy to navigate.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 13:52
    I will clarify that there is no Freedom of Information for FDA clearance/whatever/approval, either.  The Freedom of Information Act applies to the entire US government.  FDA has regulations that describe the process by which it handles FOI requests, but that's not where the freedom of information comes from.

    (Every once in a while, it actually is great to be an American.)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 6.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 06:24
    Dear James,
    nice try.  Please let us know whether this worked.

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    Ludger Moeller
    President, MDSS GmbH
    lmoeller@mdssar.com
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    Original Message


  • 7.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 08:26

    Thanks for all the replies.

    @Ludger - I am not sure what you mean? I am not looking to view any, just wondering how things will work for our own TF once we submit.

    Have a good Christmas all. 



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    James
    Head of QARA
    UK
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    Original Message


  • 8.  RE: Freedom of Information - CE Marking

    Posted 24-Dec-2019 08:50
    Dear James,
    thank you for your quick feedback.
    It certainly would make sense to monitor competitive products and to search for information anywhere as long it can be obtained properly. Indeed, I thought that this would be your intention. If a system of disclosure would exist with the NB then any manufacturer would have to review it with its PMS system.
    However, since your questions did go in the opposite direction – to protect the information you provide to the NB we would suggest to clarify this with your notified body and indeed it may be a selection condition.

    We also recommend to exclude any critical confidential information from any files if possible. Annex I (the most critical one) Annex II and Annex III outlines the requirement and how that is being taken care of may be reflected in the agreement you have with your notified body.

    I would be more concerned with the new requirement in Article 10 point 14

    "If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user,..."

    The MDD states the information shared with the CA shall be kept in confidence in order to foster vigilance reporting. That is gone!!

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    Ludger Moeller
    President, MDSS GmbH
    lmoeller@mdssar.com
    ------------------------------

    Original Message


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