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.
- Assist you to register to EUDAMED.
- Validate the manufacturer's registrations on the EUDAMED portal.
- Work directly with the manufacturer at no costs to you as importer.