Importer / Distributor of In-Vitro diagnostics to Europe

Importer / Distributor of In-Vitro diagnostics to Europe

Did you know that as of May 2022, as an importer or distributor of in-vitro diagnostics devices, you have the legal obligation to ensure that the devices you are making available on the EU market comply with the IVDR?

By distributing or importing in-vitro diagnostics from manufacturers based outside the European Union, you must add your company details, review labels, 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:

  • Verify that  a QMS is in place and will ensure that technical documentation has been draw up according to IVDR annex II an II and appropriate conformity assessment procedure has been performed.
  • Provide a vigilance contact point.
  • Store the product technical documentation for over 10 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.

Let us deal with the regulatory work to ensure compliance. So you can focus on your business!

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