Distributors and importers: new MDCG Q&A

The MDCG has published a new Q&A document with the aim to provide more details on the implementation of Articles 13 and 14 and other related obligations for importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The Q&A addresses the following topics:

  • Distinguishing importers and distributors;
  • General Obligations;
  • Verification Obligations;
  • Registration Obligations;
  • Other.

It also gives practical examples on:

  • How to determine the importer when the physical operation of “placing the device on the market” is sub-contracted;
  • How a manufacturer established in the Union can send devices directly to an EU based distributor without becoming an importer;
  • How to consider an entity physically bringing medical devices manufactured in a third country into the Union when such devices are not placed on the Union market and are supplied directly on to a third country distributor.

Although it is a useful source of information, this document cannot be considered exhaustive and should be integrated (among others) with:

  • The MDR/IVDR;
  • The Regulation (EU) 2019/1020 on market surveillance (where applicable to the MDR/IVDR);
  • The horizontal guidelines of the “Blue Guide” of the European Commission.

Overview of the Questions and Answers

  • What determines whether a natural or legal person acts as a distributor or an importer?

Key is the definition of “placing on the market”. If a legal entity established in the Union obtains a device from an economic operator established in a third country and places an individual device on the Union market, that entity is acting as an importer of the individual device. Where a legal entity sources devices from importers, distributors or manufacturers established in the Union and further distributes those devices to other entities, they are considered distributors.

  • Can individual shops, community pharmacies, retailers, or other persons be considered distributors?

Yes, a distributor is any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service (see Article 2(34) MDR/Article 2(27) IVDR). As such, individual shops, pharmacies or retailers or other natural or legal persons meeting this definition, are considered distributors.

  • Does an EU based distributor become an importer if it obtains its products directly from a non-EU based manufacturer or distributor?

Yes, as the concept of placing on the market refers to each individual product, not the type of product.

  • Do importers and distributors have registration obligations in EUDAMED?

Importers of a device have to register in EUDAMED, while distributors do not have to. However, as per Article 30(2) MDR/Article 27(2) IVDR, distributors may be subject to national registration requirements of member states in which they have made the device available.

  • Can there be multiple importers of a device model from one manufacturer?

Yes, the obligations of device importers will apply to any entity meeting the definition of Article 2(33) MDR/Article 2(26) IVDR. It is not possible however, to have multiple importers of the same individual device.

  • Do 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. Some of these obligations, serving to support a well-functioning vigilance and market surveillance system as well as proper registration of economic operators and devices, therefore apply. These include in particular, for importers Article 13(2), last paragraph, (4), (6)-(8), (10) MDR related to reporting and cooperation and for distributors, Article 14(2), last subparagraph,(4)-(6). However, verification obligations related to labelling and UDI Requirements established under the Regulation do not apply.

  • Do importers and distributors have any obligations with regards to device traceability?

Importers and distributors should implement solutions to meet traceability obligations outlined in Article 25 MDR/Article 22 IVDR. In addition, they are subject to the Article 27(8) MDR/Article 24(8) IVDR obligations for economic operators to store UDIs for class III implantable devices for which they have supplied or which have been supplied to them.

You can find the full Q&A document in our dedicated Library!

Leave a Reply

Your email address will not be published.