MEDIMARK EUROPE

2019 Forms revised : 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 PC files to help them to build their Technical files.We give them free of charge.

Since the installment of the European Databank for MD and IVD products in May 2011, we notify the French Competent Authority on a special bilingual form with English and (...)

FREE SALES CERTIFICATES

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

For answering to European Competent Authorities requests in terms of European availability and product notification/registration, we request you a list of documents from your Technical file.

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 format given by the EU Vigilance Guidelines. (...)