Although the MDR and IVDR define the terms importer and distributer and specify their respective obligations, certain aspects still remain unclear. In light of this, the MDCG has published a question and answer regarding Article 13 & 14 of the MDR and IVDR respectively, entitled MDCG 2021-27 with the aim of clarifying these aspects.
The Q&A document clarifies certain topics, such as distinguishing between importers and distributors, adding some more information to the definitions found in the MDR/IVDR, and highlighting the general obligations of both actors as well as the verification and registration obligations. Lastly, the document provides three practical examples that will help readers understand the concepts discussed in this Q&A better.
Some important aspects to highlight from this document are:
- Question 5 of the document, which indicates that pharmacies, shops and retailers would be considered as falling into the definition of distributers and would therefore need to meet the obligations of Article 14 of the MDR. Additionally, these operators will assume the role and responsibilities of an importer, as specified in Article 13, if they obtain the device directly from a non-EU based manufacturer.
- Question 8 of the document, which specifies that accompanying documentation containing the importer’s details, may be separate from or affixed to the individual device, as long as it accompanies the individual device throughout the supply chain and reaches the end user. This means that the details of the importer should be on the Label, IFU or any additional leaflet that accompanies the device.
- Although not a new concept, question 19 indicates that Article 7 also applies to the importers and distributers of the device. Article 7 specifies that it is prohibited for such actors to use text, names, trademarks or pictures that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance on the labelling and IFU.
The guidance document can be accessed using the following link.
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