Responsibilities of a SaMD Importer

As we’ve noted in a previous article, under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 non-EU/EEA based manufacturers of SaMD should assign an importer for compliance purpose. Manufacturers that have no importer assigned run the risk of their end users being considered the importer.

We’ve also discussed some of the impacts of Article 13 of the MDR/IVDR on manufacturers of SaMD regarding liability, listing and labeling. It is fundamental that manufacturers and their importers have an agreement in place that clearly delineates the roles and responsibilities of each party, including their regulatory responsibilities under the MDR/IVDR. 

Using an Independent Importer

In a scenario where a non-EU/EEA based manufacturer is supplying SaMD directly to end users in the EU/EEA (e.g. via direct internet download) and using an independent third party as their importer, it is critical that this agreement clearly indicates how the third party obtains the SaMD (via a transfer of ownership, possession, or any other property right, which does require the physical handover of the product) and places it on the EU/EEA market (i.e. first making available) in order for this third party to fulfill the established definition of ‘importer’. 

In such scenarios, it is equally critical to establish in the agreement that the third party obtains each individual device in such a manner to avoid the possibility of other legal entities being viewed as importers. As outlined in MDCG 2021-27, there can be multiple importers of a device model from on manufacturer, but it is not possible to have multiple importers of the same individual device.  

In addition to the general obligations of importers established under Article 13, there are several requirements with which a SaMD importer shall comply.

SaMD importer responsibilities: 

1. 1. 1. Ensure that there are no misleading claims in the labelling, instructions for use, making available, putting into service and advertising of devices, as required under Article 7. Where misleading claims are identified by the importer, in accordance with Article 13(2), it shall not place the device on the market until such claims are corrected or removed. Furthermore, an importer should inform the competent authority of the Member State in which it is established if it believes that a device presents a serious risk or is a falsified device.
      2. Achieve an appropriate level of traceability of devices (Article 25 MDR/Article 22 IVDR). In the above scenario, the importer is neither directly supplying nor receiving the device therefore conformity with Article 25(2) MDR/Article 22(2) is not applicable, however it is still necessary for the importer to co-operate with the manufacturer or authorized representative to ensure that device traceability measures are appropriate. In the scenario above, this could comprise a verification of the device traceability controls established by the manufacturer. 
      3. Verify that the manufacturer or authorized representative have reported the necessary information to EUDAMED, within two weeks of a device (other than a custom-made device) being placed on the market and reporting back to those actors where such information is incomplete or incorrect (Article 30(3) MDR/Article 27(3) IVDR)). This is in addition to the other EUDAMED-related responsibilities called out in Article 13 and Article 31 MDR/Article 28 IVDR. 

As noted in MDCG 2021-27, while importers may sub-contract some operational activities to other organizations, this does not absolve an importer from its legal obligations or potential liability. An importer cannot delegate their legal responsibilities to another importer. Therefore, as mentioned above, it is critical that the roles and responsibilities of importers and manufacturers of SaMD be clearly established in an agreement between both parties. 

For non-EU/EEA SaMD manufacturers contemplating using an independent third party as their importer, MedEnvoy offers EU Importer services. Should you have any questions regarding our services, get in touch. 

Learn more about how MedEnvoy can help:

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