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