,MFreyr - Your Trusted EU Importer as per EU MDR/IVDR – Overview
A device importer under the EU MDR (EU 2017/745) and IVDR (EU 2017/746) is defined as any natural or legal person established within the Union that/who places a device from a third country on the Union market. Freyr, as an EU MDR and IVDR Importer service provider, is responsible for bringing medical devices into the Union market from outside the EU and ensuring that these devices comply with the relevant EU regulations before they are made available on the market.
Freyr is your one-stop shop Regulatory partner in medical devices. We offer Regulatory support, including EU MDR and IVDR Importer service for non-EU manufacturers, ensuring the obligations of the importer under Article 13 of the EU MDR and EU IVDR for placing compliant devices on the union market.
Why Do You Need an EU MDR and IVDR Importer Service?
It has important and clearly defined responsibilities. To a large extent, It build on the type of responsibilities that a manufacturer based in the EU is subjected to (refer to the ‘Blue Guide’ on the implementation of EU product rules 2022).
The EU device importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products but has a key role to play in guaranteeing the compliance of imported products.
Although the definition of importer applies broadly to any entity introducing devices to the Union market for the first time, designating a single independent Regulatory EU Importer offers numerous advantages for the manufacturer. These includes:
- Having one point of contact for the devices placed on the Union market will streamline the operations, reduce the complexity, and eliminate the need for multiple collaboration s with different importers.
- A single EU importer will ensure compliance with the EU requirements, and this will streamline the process.
- Having one EU importer will reduce the complexity for the manufacturer by listing only one EU importer on labels and documentation, as well as streamlining data flow within EUDAMED.
- The distributors that import the device outside of the EU, will automatically become EU importers, and, in turn, are required to take the importer obligations. In most cases, the distributors are not willing to take this role.
- Having only one EU importer will centralize the PMS activities for the manufacturer.
As your Regulatory EU Importer, before placing a device on the Union Market, Freyr will verify your compliance with EU requirements as per Article 13 EU MDR / EU IVDR:
- CE Conformity: Ensuring your Medical Device is CE marked.
- EU Declaration: Verifying that the EU Declaration of Conformity is present for your medical device before placing it in the Union Market.
- Manufacturer Identification: Confirming that the manufacturer is identified on the device
- Authorized Representative (AR): Ensuring that an authorized representative has been designated by the non-EU manufacturer.
- Labelling: Verifying if the Medical Device is labeled according to EU MDR/ IVDR and is accompanied by the instructions for use.
- UDI Assignment: Verifying if a Unique Device Identifier (UDI) has been assigned by the manufacturer.
With Freyr's dependable EU MDR and IVDR Importer services, you can guarantee your medical devices' seamless compliance and market access. Get in touch with us right now to expeditiously access the Union market and streamline your regulatory journey!