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  • 1.  Who is the Relevant Competent Authority for Medical Devices in Europe?

    This message was posted by a user wishing to remain anonymous
    Posted 14-Dec-2022 09:44
    This message was posted by a user wishing to remain anonymous

    I am going through our Vigilance/Reporting process for Europe. We make a Class IIa medical device with a Class I accessory.

    All of the guidances I can find on vigilance state that, in case of an incident or FSCA, we should notify the 'relevant' Competent Authority, but I'm struggling to understand who is the 'relevant' Competent Authority/Authorities.

    If we had a FSCA for the Class IIa product, and we needed to do the FSCA in Switzerland and France; our NB is located in Sweden; our AR is located in the Netherlands.... do I notify SwissMedic, ANSM, and the MPA, and the HYCI?

    What if we only have an incident and NOT an FSCA? How does that change the reporting requirements?


  • 2.  RE: Who is the Relevant Competent Authority for Medical Devices in Europe?

    Posted 17-Dec-2022 09:34
    Hello Anon

    It is a bit ambiguous. The regulation envisions a fully functional EUDAMED that automatically grants information access to all the relevant parties. In the interim, expectations vary somewhat between ARs, NBs, and CAs. You might review your NB and AR agreements or ask if they have a current policy or preference or interpretation on the subject.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Who is the Relevant Competent Authority for Medical Devices in Europe?

    Posted 19-Dec-2022 01:51
    Edited by Richard Vincins 19-Dec-2022 01:51
    Hello Anon,

    Indeed as Anne has said quite ambiguous with wording which let Member States and Commission decide and determine reporting of incidents and FSCAs.  For serious incidents it is more clear as it needs to be reported in the Member State in which it occurred, but you should also notify your local Competent Authority (or where your Authorised Representative is located), and you should also notify your Notified Body (if you have one) - based on the contract.  Field Safety Corrective Actions (FSCA) or recalls are definitely more ambiguous with the key denominator being notification of countries/Member States where the product is being recalled from - not necessarily only the one Competent Authority (CA).  However, the agreement of the FSCA should be done with your local CA (or AR location) according to the current process.  I have experienced in the past where even Member States which had no product in their country heard of a recall and asked why we did not notify them ... shrugs.  As Anne pointed out the EUDAMED system, when fully functional, will address this as the reporting will be done in a central electronic system.  Until then, would recommend the 'relevant' Member State/CA is countries where product is being taken from the market, at a minimum, but you might need to notify others where similar/same product is sold as well - not just the object of the recall.  Strongly recommend writing in your own internal procedure how this is managed, communicated, and completed for FSCA in Europe.  And at this time Switzerland is not part of the European Union and no agreement, so they are treated as their own independent country for reporting, just like United Kingdom, just like United States, just like Canada, etc.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Who is the Relevant Competent Authority for Medical Devices in Europe?

    This message was posted by a user wishing to remain anonymous
    Posted 19-Dec-2022 08:28
    This message was posted by a user wishing to remain anonymous

    If there is a manufacturer based outside of the EU and the manufacturer has an AR based in the EU, the relevant competent authority to notify would be the member state where the AR is located. From what you mentioned, the AR is in the Netherlands, therefore notify the Netherlands competent authority. All affected competent authorities should be notified as well.

    A FSCA should be notified to users or customers by a FSN, which is sent out by the manufacturer or their AR; a copy of the FSN should be sent to the NB.

    For incidents, the AR must submit an initial incident report to the national competent authority, from what you mentioned, the Netherlands competent authority. Where appropriate, the manufacturer should notify distributors to act on their behalf of the incident.
    Original Message


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