Importer / Distributor of Medical Devices to Europe
Did you know that as of May 2021, as an importer or distributor of medical devices, you have the legal obligation to ensure that the devices you are making available on the EU market comply with the MDR?
By importing or distributing medical devices from manufacturers based outside the European Union, you must add your company details, review and store labels, instructions for use, CE Certificate, declaration of conformity, UDI codes, keep a register of complaints, of non-conforming devices and of recalls and withdrawals and more.
As Authorized Representative for the manufacturer, Obelis will:
- Conduct a full regulatory review of the manufacturer quality management system and technical documentation of his medical devices.
- Provide a vigilance contact point.
- Store the product technical documentation for over 10 to 15 years.
- Verify EUDAMED device registration.
- Validate the manufacturer's registrations on the EUDAMED portal.
- Work directly with the manufacturer at no costs to you as importer.