News for Medical Device Importers and Distributors

 In December 2023, the MDCG 2021-27 (concerning the obligations of importers and distributors of medical devices) was updated to respond to questions that have arisen in the market over the past two years.

The guideline begins with a definition of “importer” and “distributor,” clarifying that an “importer” is “any natural or legal person established within the Union that places a device from a third country on the Union market“; while “distributor” means “any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market, up to the moment of putting it into service.”

The main determining factor lies in the definition of “placing on the market” which automatically qualifies the natural or legal person as an importer. Therefore, even a person who does not habitually or permanently perform the role of importer, be labeled as such by introducing a medical device from abroad into an EU member state.  Furthermore, “the concept of placing on the market refers to each individual product, not to the type of product.” Consequently, an EU based distributor becomes an importer if it obtains its products directly from a non-EU based manufacturer or distributor and places the individual device on the EU market (first making it available) even if there is another importer for the same device model in the EU.

A leasing company may be considered an importer or distributor under the Regulations depending on the specific activities it carries out, however this is unlikely where it is not part of the supply chain.

The guideline also provides details on verification obligations for importers and distributors. Importers must ensure that devices are CE marked and labeled in accordance with the MDR, while distributors must verify that devices are accompanied by the information required by the manufacturer. Physical checks are therefore essential for ensuring device compliance.  The guidelines further suggest that to ensure “the importer’s details reach the end user, the importer should consider providing the accompanying documentation with the smallest saleable package of the device.”

Finally, both importers and distributors must ensure traceability of medical devices by maintaining detailed records on the procurement and distribution of devices.

MDCG 2021-27 Rev.1: Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746