Who is an EU Importer For Medical Devices?

An EU importer is a natural or legal person who places a medical device from another country into the European Market. They must ensure that devices placed in the market are Medical Device Regulation(MDR) or In Vitro Diagnostic Regulation (IVDR) compliant and meet the essential requirements like CE Marking, and EU Declaration of Conformity.

Responsibilities of an EU Importer!

  • Device labeling and instructions For Use (IFU) are legally compliant & Unique Device Identifier (UDI)
  • The device has been registered with competent authorities under the applicable database.
  • Verification of Authorized Representative designated by the manufacturer.
  • Notification and Coordination in case of any non-conformity with Authorized Representatives and Manufacturers, as well as competent Authorities when needed.
  • The Importer must be registered with EUDAMED and verify that the device is also registered under the same.
  • Keeping proper records of complaints (if any) and notifying the Authorized Rep and Manufacturer.
  • Apart from ensuring compliance of the device with CE Marking and Declaration of Conformity, they should keep copies of the EU Declaration of Conformity and other documents with them To ensure that your Medical Devices pass the test of Regulations in the EU and smooth Market Access Expansion, it is important to choose a competent & experienced expert as your EU Importer.

Additional Information

Your Sole EU Importer for Increased Independence and Compliance Verification

Cert3global is a Competent team of regulatory experts who are experienced in providing EU Importer Services to Global Medical Device Manufacturers looking for a reliable partner for increasing their Market Access. We offer internationally recognized standards of service to streamline your operations without disturbing your existing supply chain model. We ensure confidentiality by following best practices on document privacy.

Send us a query to get in touch with our experts for Free and know more.

Should You Appoint your Distributor as your Regulatory Importer?

Many manufacturers choose to appoint their distributor as an Importer. While this may seem an optimal idea here are the points to consider before you go onto that route:

  • A distributor may not have the regulatory know-how and ability to be updated with the latest happenings of the Regulatory Scenario. Hence, it is better to
  • appoint some entities which are solely in the business of Regulatory Consultation and can be reliably dealt with.
  • There is a risk of significant fines being levied by Authorities if proper compliance practices are not followed.
  • Out of multiple distributors, if you choose one as your Importer, then others may not accept that and it can affect the sales of your devices.
  • With the responsibilities of the Importer, access to Critical documents (like Technical) has to be shared.
  • A distributor may be selling similar devices to competitors, which can invite a conflict of interest.

Hence hiring a regulatory operator who is solely engaged in providing consultation services to manufacturers and out of the business of selling medical devices can be a better idea for your medical devices. Cert3global can assist you in this process without disrupting your existing operations or supply chain.