Regulatory Open Forum

 View Only

  • 1.  Posting of Notified Body Certificates

    This message was posted by a user wishing to remain anonymous
    Posted 30-Nov-2020 16:23
    This message was posted by a user wishing to remain anonymous

    Hi,

    For years, we have posted our Notified Body certificates (Design Exam, FQA, etc) in our building lobby.  Is there a requirement/expectation to post these certificates publicly? 

    Thanks!



  • 2.  RE: Posting of Notified Body Certificates

    Posted 01-Dec-2020 05:31
    Hello Anon,

    No, there is no requirement.  This was really a lay-over from the ISO 9001 world showing "we achieved our certification and we want to display it proudly".  Maybe also a kind of moral booster for employees seeing this on a daily basis understanding the certification and what the company is striving for a quality mentality.  What is important is having the certificates in a quality management system so they are readily retrievable.  It is a question I often ask during audits to see copies of ISO certs, CE Certs, licenses, etc., and always challenging when the company is looking around for them and can not find them.  So I recommend these certificates/licenses are assigned document numbers and maintained in the QMS.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Posting of Notified Body Certificates

    Posted 01-Dec-2020 05:42
    Hi anon, it is not required to make your CE certificates and Declarations of Conformity publicly available in any which way, so also not in your building lobby. But you are allowed to, also in any which way, eg. on your website.

    Under the MDR things may change a little, because the other economic operators (authorized representative, importer, distributor) have to fulfill their obligations, amongst others verifying DoC and CE certificate or even have a copy of them (and other subjects). Until the EUDAMED is completely functional you have to have a way of working for making these available (and updated) to them in a suitable way. Using your website (or a protected part) as communication tool may be a suitable way.

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: Posting of Notified Body Certificates

    This message was posted by a user wishing to remain anonymous
    Posted 02-Dec-2020 09:10
    This message was posted by a user wishing to remain anonymous

    Thank you Richard and Peter!
    Original Message


Related Content