Services we provide for you

We offer Import services according to the MDR / IVDR

Searching for a trusted importer which 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 the MDSS group ensures the high quality of service with more than 25 years of experience in the European Regulatory Affairs.

As your Importer, we will:

  1. Place your devices in the European Market
  2. Verify that the documentation is in compliance with the European requirements.
  3. Verify that the device is registered in the electronic system in accordance with Article 29 of the MDR/IVDR.
  4. Complete the electronic registrations when necessary.
  5. 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.
  6. 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.
  7. Immediately forward any complain or valuable information to the manufacturer and its authorised representative.
  8. Cooperate with the manufacturer and requests from the Competent Authority.