Import and Trade of Medical Devices in the EU

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Individual support for distributors and importers in fulfilling their legal obligations under MDR/IVDR

The MDR and IVDR place a heavy burden on individual economic operators. The responsi­bilities of distributors and importers of medical and IVD medical devices have increased signi­ficantly – and with them, the liability risks. 

However, many distributors and importers are unclear about the exact require­ments placed on them and how they can implement these as easily as possible to fulfill their legal obligations and avoid problems.   

Our experts resolve all uncer­tainties in your role as a distributor or importer of medical devices in the European economic area

Clarity

Our experts explain the require­ments of the MDR and IVDR and the obligations you must fulfill as a distributor or importer. This way, you know exactly what tasks and efforts to expect. 

Legal Safety

We show you how to fully and correctly imple­ment your tasks and duties in your daily practice. That will help you gain legal safety and avoid sanctions from the authorities.

Competent Support

Our team is not only competent but also helpful. We support you in defining your roles according to your individual constellation, solve compre­hension problems, and answer all questions.

Remote Meeting on the Computer

Customized solutions for implementing MDR/IVDR in daily practice and individual consultation on all your questions

As part of a workshop, an expert will discuss the relevant regulatory basics of the MDR and IVDR with you as well as the practical significance of the requirements according to your constel­lation. He or she will solve any compre­hension problems and answer all your questions. 


​​​​​​​The collaboration proceeds as follows: 

01

Appointment

Upon request, we will arrange an appoint­ment for your indivi­dual workshop. It will take place remo­tely and usually lasts around four hours.
02

Preparation

We require your initial key ques­tions and some back­ground information before the appoint­ment. If necessary, we will first determine your role(s).
03

Workshop

In the workshop, we will first dis­cuss the regula­tory require­ments for importing or making available medical devices in the European economic area.
04

Discussion and Questions

We will then clarify all remaining questions and discuss the prac­tical signifi­cance of the require­ments according to your constellation.

Get in touch, and our regulatory experts will be happy to help you carry out your tasks as a distributor or importer.

Contact us, we're happy to help!
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+49 7531 94500 20

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