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  • 1.  Adverse Event Reporting vs Vigilance Reporting

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2017 17:46
    This message was posted by a user wishing to remain anonymous

    What is the difference between the two? 

    Also, could we use these two names interchangeably?

    Regards,



  • 2.  RE: Adverse Event Reporting vs Vigilance Reporting

    Posted 26-Oct-2017 02:23
    Edited by Anna-Sophie Geiersberger 26-Oct-2017 02:25
    ​I would say, for medical devices, the adverse event reporting usually is for events during clinical trials, so for not-yet CE-marked products.
    The vigilance reporting is the reporting of events which appear with products, which are already CE-marked and available on the market. So sometimes event from trial participants also are vigilance events, when the product meanwhile is CE-marked and available on the market.


  • 3.  RE: Adverse Event Reporting vs Vigilance Reporting

    Posted 26-Oct-2017 05:14
    ​

    I think Anne-Sophie is right. For the sake of clarity, I want to add the following. 

    Just have a look in ISO 14155:2011 "Clinical investigation of medical devices for human subjects - Good clinical practice", definitions 3.2 (adverse event), 3.36 (serious adverse device effect), 3.37 (serious adverse event), and 3.42 (unanticipated serious adverse device effect). 

    And have a look in MEDDEV 2.12-1 (rev 8 of January 2013) "Guidelines on a medical devices vigilance system". § 2 (Introduction) starts with saying that "These guidelines describe the European system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical Device Vigilance System". And look in § 4 for the definitions of incident (4.10) and FSCA (4.6).

     

     



    ------------------------------
    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.
    Lausanne
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: Adverse Event Reporting vs Vigilance Reporting

    Posted 27-Oct-2017 12:18
    ​If your goal is to use wording that is appropriate for both US and EU, you could try "incident reporting" or "medical device reporting".  We have a procedure on medical device incident reporting that covers several regions, and the title is "Medical Device Reporting".

    ------------------------------
    Carrie Osing
    Regulatory Affairs Manager
    Bisco, Inc.
    Schaumburg IL
    United States
    ------------------------------

    Original Message


  • 5.  RE: Adverse Event Reporting vs Vigilance Reporting

    Posted 27-Oct-2017 12:45
    ​

    Nice clarification, Carrie ! I just want to make a comment about having one procedure covering reporting obligations for multiple regions (jurisdictions). Over time, on multiple occasions, I have seen citations in FDA Warning Letters for companies that appeared to have one procedure combining language or requirements for multiple regions. This was done in such a manner that FDA felt very uncomfortable with this, fearing that FDA reporting obligations were not assured to be met. The most recent example comes from a Warning Letter to EuroDiagnostica AB (Malmo, Sweden) as per the below link and excerpt from that Letter. So, just make sure your single procedure addressing reporting obligations for multiple regions properly and unambiguously implements the precise wording and requirements from each region. 

    Link        https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578374.htm  

    Excerpt
    b.  The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803.

     

    Hope this helps and with kindest regards,



    ------------------------------
    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.
    Lausanne
    Switzerland
    ------------------------------

    Original Message


  • 6.  RE: Adverse Event Reporting vs Vigilance Reporting

    This message was posted by a user wishing to remain anonymous
    Posted 30-Oct-2017 09:25
    This message was posted by a user wishing to remain anonymous

    From a medical device perspective, for a product that is commercialized and being marketed after the appropriate clearance (e.g. PMA, 510(K), CE marking), adverse event reporting and vigilance reporting (more EU term)  are both interchangeable and are applicable as part of Post Market Surveillance. Both are typically triggered based on defined thresholds and advisory limits that are established to meet regulatory requirements and standards as well as company established requirements.
    Original Message


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