The EU MDR/IVDR establishes specific regulatory obligations for economic operators, including importers.
The concept of “placing on the market” is fundamental to the EU New Legislative Framework and the ‘Blue Guide’ on the implementation of EU product rules 2022 clearly states that placing on the market is considered not to take place where a product bought by a consumer in a third country while physically present in that country and brought by the consumer into the EU for the personal use of that person. However, it also states that this exception does not include products which are shipped by the economic operator to the consumers in the EU, such as the of products bought online and shipped to the EU.
EU MDR Economic Operators Obligations
Under the EU MDR/IVDR, specific regulatory obligations are established for economic operators including importers. While the applicability of these requirements to commercial importers is clear, the question remains: For direct-to-consumer devices and IVDs shipped into the EU from a third country, who becomes the importer? We’ve outlined what you should know in this case about the EU MDR economic operator obligations.
MDCG 2021-27, together with the Blue Guide, goes some way to providing guidance on this topic.
Guidance on Article 13 Importer obligations
This guidance emphasizes that the importer obligations established under Article 13 of the MDR/IVDR are not applicable to consumers where they purchase the product in a third country while physically present in that country and then bring it into the EU for their personal use. Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question. While it requires the manufacturing stage to have been completed, it does not require the physical handover of the product.
Direct-to-consumer shipped devices and IVDs manufactured outside of the EU
Therefore, for devices and IVDs manufactured outside of the EU, it is possible that such devices and IVDs are placed on the market through such an agreement with a third party acting as importer prior to any physical handover of the product during direct-to-consumer shipping. However, in the absence of an importer having been assigned by such a manufacturer, based upon the content of the Blue Guide and MDCG 2021-27, it appears as though consumers would be viewed as the importer of direct-to-consumer shipped devices and IVDs. Subsequently, they would be subject to all importer obligations established under the MDR/IVDR.
Must have clear indication of how the Importer obtains devices
It is critical that the roles and responsibilities of importers and manufacturers of devices and IVDs be clearly established in an agreement between both parties, including a clear indication on how the importer obtains devices/IVDs (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’.
Ensure compliance with EU MDR/IVDR
For non-EU/EEA device and IVD manufacturers contemplating the use of an independent third party to serve as their importer, MedEnvoy offers EU Importer services. MedEnvoy ensures continues compliance remotely without disrupting your supply chain.
Learn more about MedEnvoy’s Importer service
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