Are European Authorized Representatives subject to unannounced audits by Notified Bodies?
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 (…)
Most recent articles
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UNANNOUNCED AUDITS BY NOTIFIED BODIES
27 June 2014, by Rene Clement -
FIELD SAFETY CORRECTIVE ACTION
27 June 2014, by Rene ClementRecall: 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 AR
should then submit the FSN for approval to a CA. Meanwhile, the manufacturer should be mining its traceability system for (…) -
FIELD SAFETY CORRECTIVE ACTION
27 June 2014, by Rene ClementRecall: 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 (…) -
FIELD SAFETY CORRECTIVE ACTION
27 June 2014, by Rene ClementRecall: 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 (…) -
FIELD SAFETY CORRECTIVE ACTION
27 June 2014, by Rene ClementRecall: 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. -
UDI, Eudamed and Medical Device Regulation
16 June 2013, by Rene ClementThe European Commission published its recommendation for a common framework for a unique device identification (UDI) system for medical devices in April 2013.
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The 2013 Revision Of The EU Vigilance Guidelines
27 April 2013, by Rene ClementRevision 8 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on July, 2013. It may lead you to update your vigilance procedure.
The main addition in this new guideline version concerns the In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products which are now explicitly included within the scope of the vigilance system. Additional notes are related to the “Indirect harm” concept. -
EU Medical Device Regulation’s Scrutiny Procedure Could Hinder CE Marking Process
15 February 2013, by Rene ClementAs soon as the European Commission published the proposed new European medical device regulations on September 26, 2012, industry stakeholders raised concerns about some of its provisions. Pan-European industry association Eucomed, which has entered into an alliance with the European Diagnostic Manufacturers Association (EDMA) to form MedTech Europe, and British industry association ABHI have questioned aspects of the regulation, especially the need for the so-called scrutiny procedure. The (…)
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The new French Decree: Advertising visa for high risk medical devices
27 November 2012, by Rene ClementThe French decree regarding the list of medical devices for which advertising to healthcare professionals shall obtain a prior authorization of ANSM (National Safety Agency of Medicines and Health Products), has been published on October 03, 2012. Such authorization is referred to as ‘’visa de publicité’’ (advertising visa) and is applicable to all advertising materials utilized after January 1st 2013, meaning that all manufacturers required submitting their current marketing materials to ANSM.
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EU Medical Device Directive Revision - What’s going on ?
27 September 2012, by Rene ClementThe publication of the Commission’s revision proposal to the Council and European Parliament should be done during this month of September 2012. However, It will be only the beginning of the Ordinary Legislative Procedure where the Council and European Parliament discuss the proposal and bring amendments in order to agree upon a common text which will be most likely published in early 2014 before the new European Parliamentary elections.
Since the text should be published as Regulations and (…)