Our contracts

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 (…)

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 (…)

Service Proposals and model of contract for Medical Devices Service Proposals and model of contract for In Vitro Diagnostic Medical Devices Questionnaire for receiving a proposal estimate