In order to answer to the different levels of risks of Incidents associated with the various types of Medical Devices, MediMark® Europe proposes two different options for US Manufacturers.
Services provided for both options
- Use of MediMark® Europe’s name and address for CE Mark labelling
- Operational assistance in designing multilingual labels in compliance with the Directive 93/42 EEC requirements and soon in application MDR 2017/745
- Electronic support for building Technical Files ; Server for upload and maintenance of permanently-updated TFs
- Notification to ANSM, the French competent authority for loading into the European Data Bank
- Review and maintenance of the part A of the Technical Files. Presentation to the Competent Authorities upon requests
- Answers to any questions relating to European Regulatory Environment
- Providing of documents included in MediMark® Europe database
- All office supplies including standard registered mail, phone, fax
- NEW ! 7 Assessment Reports free for Incident Classification
Option 1
The first option includes in addition some incident reports (initial and final), and notification of first Recalls, for a fixed monthly fee payable every quarter. This fee is based on classification of the devices and the number of product families.
Option 2
This option is composed of a flat base fee based on classification of devices and the number of product families, payable annually or six month payment schedule and fees for Incidents.Vigilance fees , if any, will be determined in relation with the nature and severity of the Incident reported.
Notes : Fees are payable by wire transfer or by bank check in US dollars. There is no indexation on the exchange rate between Euro and US dollar.Fees do not include travel expenses made after manufacturer’s approval for meeting with Competent Authorities
