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In Vitro Diagnostic Medical Devices

In order to give flexibility to the IVD manufacturers for a progressive introduction of their product lines into the European Market, the fee structure is constituted of an annual administrative fee and a “per product designation fee” which will be invoiced only at the date of their notification to the concerned European Competent Authorities and only for the part of the year remaining to the next anniversary date of the contract. They will be then added to the annual administrative fee invoice for avoiding multiple bank transactions.

Services provided for

  • Use of MediMark® Europe name and address for CE Mark Labeling.
  • Operational assistance in designing multilingual label in compliance with the Directive 98/79/EC and soon in application IVDR 2017/746 requirements.
  • Private Server for uploading and maintaining technical files.
  • Reviews technical files ; holds Part A of TFs and offers access to/for the information of Part B - to be presented to Competent Authorities upon request.
  • Makes Product Notification/registration to the European Data Bank through ANSM ( French National Competent Authority).
  • Consulting for initial compliance and maintenance of compliance in regards to the above activities.
  • Permanent hot line to advsing about Europe.
  • Assessment Report for incident classification and reportability.
  • Conducts Incident Reporting and coordinates between manufacturer, distributor and Competent Authorities, including final report. Participates to any meeting requested by Competent Authorities for negotiation of field corrective actions..
  • Notifies Voluntary Recall to the concerned Competent Authorities and answers to their follow-up questions.
  • All office supplies, express mail, phone, fax, etc,

Notes : The fees are established on a price list and are guaranteed for three years after the contract signature. Fees do not include the notification taxes which may be requested by several European Competent Authorities , and travel expenses made after manufacturer’s approval for meeting with hospital users, Competent Authorities or European Commission in case of very severe incident.

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