MEDIMARK EUROPE

Last Revisions of the Forms: As you may know, EU NCAs make a strong distinction between forms dedicated to distributors/importators and those dedicated to end users.

It’s now formalized with the requested use of the templates you’ll find here attached.

In order to save time for our customers, we have created series of Templates to help them to build their Technical Documentations.We give them free of charge.

FREE SALES CERTIFICATES

Our customers submit us their draft of labels. We check them and propose corrections, if any, for full compliance with the new Regulations and EN Standards.We also provide (...)

For answering to the requirements of the new MDR & IVDR Regulations (Article 11) regarding the availability of a permanent updated Technical Documentation at your EAR office, we offer you a private space on our internal fully securized Cloud for easy upload of all your documents.

When an incident or near incident is reported to us by the manufacturer, we conduct within 48 hours an analysis of the event versus the European Vigilance Guidelines to (...)

In case the Incident is reportable, we fill in, after agreement with the Manufacturer, an initial incident report according to the last MIR format and Annexes A-G. We always (...)