Searching for a trusted Importer for your products who will ensure a safe arrival to the European Market?
MDSS-Impex GmbH provides the most complete and fastest import process in Europe. Being part of MDSS ensures the high quality of service with 30 years of experience in the European Regulatory Affairs.
MDSS-Impex GmbH as the Importer of your products will:
Place your devices in the European Market
Verify that the documentation is in compliance with the European requirements.
Verify that the device is registered in the electronic system in accordance with Article 29 of the MDR/IVDR.
Complete the electronic registrations when necessary.
Ensure that, while devices are under our responsibility, storage or transport conditions do not jeopardise its compliance with the general safety performance requirements set out in Annex I and with the conditions set by the manufacturer.
MDSS Impex will have a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them.
Immediately forward any complain or valuable information to the manufacturer and its authorised representative.
Cooperate with the manufacturer and requests from the Competent Authority.
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