EU MDR Importer
Why you now need an EU Importer
With the introduction of the European Union’s (EU) new Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), manufacturer, distributor, and authorized representative responsibilities have been more clearly defined, with the importer taking on a major new role. As such, the MDR/IVDR has put more burden and costs on the industry to ensure compliance with the new regulations. With an office in The Netherlands, our partner MedEnvoy offers an independent importer service designed to meet your MDR/IVDR obligations while minimizing product release and shipping process disruption.
Our Partner MedEnvoy can act as your importer in the EU, UK and Switzerland!
EU Importer Responsibilities
The EU importer role is not new, but it is now mandated under MDR/IVDR Article 13. Our Partner MedEnvoy, can help you meet this critical requirement. Here are some of the mandated tasks we perform:
- Check EUDAMED registrations
- Verify that your labelling meets EU MDR/IVDR requirements and IFUs exist
- Ensure UDIs are assigned
- Verify that the EU declaration of conformity and technical documentation exists
- Verify that the correct conformity assessment procedure has been performed
- Confirm that EU Importer and Authorized Representative are properly identified
- Verify that storage and transportation requirements are fulfilled
- Inform the manufacturer and Competent Authority if the device poses a serious risk/is not in conformity
- Maintain a register of complaints
- Check device ID within supply chain
How the EU Importer process works
Our Partner MedEnvoy, has developed a process that prevents duplication of efforts among your EU distributor(s) and EU Authorized Representative. We utilize technology to streamline the review and approval of your documentation and other EU obligations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures to prevent redundant activities from being performed while ensuring your compliance with EU MDR or IVDR regulations.
Responsibilities that are specific to the EU importer will be put in place and supported by procedures and work instructions that MedEnvoy will co-develop with you during our onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into the EU.
Have a subsidiary in the EU?
Manufacturers with an established legal entity in the EU can designate that entity as their Importer. Our partner MedEnvoy can provide “white label” back office services to your EU subsidiary to ensure all EU MDR/IVDR importer obligations are being met. Your subsidiary name goes on your labelling as an importer!
Benefits of selecting an Independent EU Importer
- Your importer must be identified on your product labelling. You maintain the flexibility to change distributors without reprinting all labelling.
- The importer must have permanent access to confidential technical documentation. We have no commercial interest in your devices, but distributors certainly do.
- Having one company act as your single Swiss, EU and UK importer will streamline the management of contracts, labelling, shipping and overall compliance for all devices sold throughout Europe.
EU Importer Fee Structure
We charge the following fees for companies importing devices into any country covered by the MDR or IVDR.
- Onboarding fee (one time)
- Annual importer service fee (based on the expected number of annual shipments)
NOTE: We can offer a multi-service discount if you also work with our Partner MedEnvoy as your Swiss and/or UK importer.