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    Are European Authorized Representatives subject to unannounced audits by Notified Bodies?

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    2013 -09-23 NB Audits EU Recommendations

    The attached EU commission recommendations regarding audits and assessments performed by the notified bodies does not make any difference between standards audits/assessments and unannounced audits in the Article 2 of Annex 2 and Article 2 of Annex 3:

    " 2. Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer’s critical subcontractors or crucial suppliers if this is likely to ensure more efficient control. This applies in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier."

    Since MediMark Europe has never been audited by a Notified Bodies for almost 20 years of EAR activities, there is few chances to be audited for an unannounced audit.The main reasons are probably:
    - MediMark Europe is certified to ISO 9001
    - All Vigilance documents written by MediMark Europe and copies of communication between MediMark Europe and EU competent authorities can be found at the manufacturer’s site.


    Recall: What should be considered for preparing and initiating a voluntary recall ?

    ANSWER:Having concluded that a recall is necessary based on a formal, written risk analysis, the manufacturer should prepare an FSN based on the sample form in the MEDDEV 2.12-1 rev 6 document as well as a user recall response sheet (which is not appended in the guidelines). The ARshould then submit the FSN for approval to a CA. Meanwhile, the manufacturer should be mining its traceability system for a list of affected distributors with product references, lot numbers, date of shipping and, of course, full distributor contact information. A cover letter prepared by the manufacturer should go out to the distributors explaining that an FSN with the response recall sheet translated into their national language will be sent by fax or mail to affected users. This letter should also remind distributors that they must send a copy of their translated FSN and affected users list to the manufacturer and/or the authorized representative, because this information will be requested by the CA.


    Recall: How, When and by Whom the NCA should be notified?

    ANSWER: With the exception of the aforementioned early-stage FSN approval, CA notifications should be made, if not before, then at the same time as the recall action. Your company’s AR is responsible for these notifications.Upon receiving the FSN, the AR must prepare a Field Safety Corrective Action report for each affected country. A template for the report is included in MEDDEV 2.12-1 rev 6. The report should include the number of recalled devices per country and an appended English-language FSN.Upon approval by the manufacturer, the AR will send out the notifications. The representative is also responsible for diligently maintaining records showing that the notifications were correctlytransmitted


    Recall: What types of CA queries can you expect directly, through your Distributors, or your AR?

    ANSWER:The type and quantity of follow-up questions from the CAs will depend on the countries. Twelve to 24 hours after receiving the notification, some will contact the AR by a return e-mail. This is typical of authorities in Ireland, France, Germany, Belgium, Portugal, Denmark, and the United Kingdom. Don’t be surprised if they bombard you with as many as 10 questions, including a nasty one along the lines of: “How can you be sure that no other lot numbers or products are affected by the problem connected with the recall?” The CA may also ask to see copies of the FSN and response sheet in its national language, a list of affected hospitals and users with full contact information, risk analysis documents, signed copies of hospital response sheets, and, when available, a completed recall close report. Some CAs, primarily from Eastern Europe, will contact the national distributor directly


    Recall: What should include the Closing report?

    ANSWER:A closing report that lists the number of units returned compared with the number that were initially shipped for each hospital/institution and the status of incidents reported during the recall should be sent to each concerned EU competent authority, even if they did not submit any questions. Your notified body may want to see the closing report, as well.

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