New Guidance Document Related to the Importer (Art. 13) and Distributor (Art. 14) Articles of the MDR and IVDR
The MDCG 2021-27 guidance offers some practical information, such as if / when a third-party logistics (3PL) provider is considered an importer as defined by the MDR/IVDR.
The guidance emphasizes that importers and distributors are required to verify the manufacturer has valid CE marking and that they cannot delegate this activity to another party.
The document also reiterates (many times over) the importer’s and distributor’s obligations around complaint handling, reporting, post-market surveillance and traceability. Therefore, manufacturers should not be surprised to have importers and distributors more concerned about device compliance under the MDR/IVDR, than they were in the past.
Notably absent from the guidance document?
Explicit answers related to direct sales: Is the end user the importer of the device, if they directly purchase and therefore place a third-country device onto the market? What about a software as a medical device (SaMD) downloaded by the end user? The given understanding is that an importer, as defined by the MDR/IVDR, is still required for direct sales. And the purchaser who first makes the product available on the market becomes the importer, whether they understand the implications of that or not. The MDCG document does not specifically addressed this topic.
Some highlights from MDCG 2021-27 are provided below. The guidance also includes “Practical Examples” starting on page 10.
|Are pharmacies, shops and retailers considered distributors or importers?||
Yes, they can be considered distributors if they buy and then sell medical devices, such as face masks. These entities must comply with Article 14 of the MDR/IVDR, which outlines the obligations for distributors.
Further, if the pharmacy or retailer obtains the product directly from the non-EU based supplier, they are then considered the importer and must comply with Article 13 of the MDR/IVDR, which outlines the obligations for importers.
|Are third party logistics providers (3PL) considered importers?||No, as long as the 3PL and manufacturer and/or importer have an agreement clearly outlining the responsibilities of each party, including that the 3PL does not take any legal ownership of the devices. For example, a logistics provider could transport and store the products as an outsourced activity for the EU importer, who ultimately takes ownership of the devices. The importer would ultimately be responsible for ensuring proper storage and transport conditions have been met by the 3PL.|
|Who is responsible for adding the importer’s information to the labelling?||Importers are ultimately responsible. Practically speaking, the importer and manufacturer can agree that another party completes the task, e.g., the manufacturer adds the information to the device/packaging during the manufacturing process. However, the importer has final responsibility to ensure this activity is executed correctly. The information must include the importer’s name and address and can be added as a sticker affixed to the label or provided as a separate leaflet, as long as it reaches the end user of the device.|
|Does the importer’s information have to identified on the labeling when shipped to the EU?||No, it’s not mandatory to have it applied pre-shipment. It can be applied once the products reach the EU importer. i.e., there should be no issues at customs if the importer information is not included.|
|Can multiple importers be included on the labeling?||No, only the single, true importer should be identified. If an importer receives product from a third country with another importer already included, the importer should determine if those products had already been placed onto the EU market. If not, and it is now newly being placed onto the market, then they should correctly identify themselves as the importer. If the product has already been placed onto the EU market in the past, then they will be the distributor for those products, not the importer.|
|Do the requirements under Article 13 (“importers”) and Article 14 (“distributors”) apply to legacy devices?||
Some of the requirements do apply to legacy devices, yes.
The items that apply are outlined in Article 120(3) of the MDR, which outlines the transitional provisions. The requirements related to vigilance, post-market surveillance, market surveillance and registration of devices and economic operators, (e.g., importers, manufacturers, authorized representatives), apply.
The aspects not covered in Article 120(3) do not apply to legacy devices. For example, adding the importer information to labeling and UDI requirements are not applicable until the device has MDR CE marking. The same can be expected for IVD legacy devices, after the IVDR date of application arrives.