The latest questions and Answers about MDR importers and distributors by the Medical Device Coordination Group
The Medical Device Coordination Group (MDCG) has released questions related to importers and distributors under Regulation (EU) 2017/75 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) covered in Article 13 and Article 14.
The document provides practical guidelines about the definition and practical examples on how to identify the importer or the distributor and what their roles and responsibilities will be.
At GrowthImports we are happy to answer any questions you still may have on your particular situation.
The full document can be download here.
- There can be multiple importers. The obligations of device importers will apply to any entity placing products in the Union. As the concept of placing on the market refers to each individual product, not the type of product,14 individual devices (of the same type) may be placed on the market by various natural or legal persons, each considered an importer and subject to the respective provisions of the Regulations on importers. However you cannot have multiple distributors for each individual device.
- The distributor may not sell products where documentation or the importer’s information is missing (see Article 14(2)(c) of the Regulations).
- Individual shops, community pharmacies, retailers, or other persons can be considered distributors as they make a device available on the market.
Companies providing third party logistics (3PLs) (such as transportation or storage) can be an importer or a distributor if they actually place or make the device available in the market. However if the function of the 3PL has purely a stock and transport function, it does not apply as the MDR importer.
- The requirements of Article 13 and 14 MDR also apply to devices certified under the Directives or ‘legacy devices. For ‘legacy devices’, the obligations outlined in Articles 13 and 14 of the MDR should be read in conjunction with the transitional provisions in Article 120(3) MDR for such devices.
- An authorized representatiove cannot perform verification checks on behalf of the importer and distributor. All economic operators must fulfil their obligations in accordance with the regulations.
- The prohibition regarding ‘misleading claims’ outlined in Article 7 of the Regulations also applies to importers and distributors.
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