Import and Distribution

The import and distribution of medical devices are subject to the new regulations (EU) 2017/745, known as the Medical Devices Regulation (MDR), and (EU) 2017/746, known as the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations establish and expand the requirements for importers and distributors in the industry. These regulations aim to ensure devices can be traced and enhance safety control and monitoring.

The information provided is intended to offer guidance and insights into the import and distribution of medical devices within the EU legal system and description of detailed requirements on the country level based on the Polish legal system. The Polish Medical Devices Act of April 7, 2022 provides detailed guidelines and regulations that supplement the above-mentioned regulations.

How can we help you?

  1. Our team is available to assist you in managing complaints and gathering feedback from the market.
  2. We can participate in evaluating information intended for users, such as user instructions, labels, and packaging.
  3. We can provide assistance with the product notification or registration processes.
  4. We are prepared to help your company achieve compliance with the MDR Medical Device Regulation.
  5. We are prepared to help your company achieve compliance with the IVDR In Vitro Diagnostic Medical Device Regulation.
  6. We will take care of the necessary paperwork for product notification.
  7. We offer consulting services for OBL/OEM (Own Brand Labeling / Original Equipment Manufacturer) collaborations.
  8. Trust us to implement an effective quality system and conduct audits for you.
  9. We can provide support in marketing and distributing your products in the EU market.