| Theme | Obligations of distributors and importers |
| Target Audience | Importers and distributors |
| Products concerned | MD & IVD |
| Documents mentioned |
MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-6 MDCG 2021-13 MDCG 2021-23 MDCG 2021-26 Regulation (EU) 2019/1020 : market surveillance Guide Bleu |
The document MDCG 2021-27 concerns, in the form of questions and answers, the obligations of importers and distributors… It completes and clarifies the provisions of articles 13 and 14 of the DMD and DMDIV Regulations: suspicion of non-compliant products, registration on the EUDAMED database, traceability, etc. Furthermore, the distinction between importer and distributor is clearly established, in view of the concepts of placing on the market, making available on the market and putting into service.
The MDCG guide specifies in which cases the distributor may become an importer.
It is also reminded that the obligations incumbent on each economic operator cannot be delegated.
Three practical examples, allowing to distinguish the status of importer or distributor, are presented at the end of the guide.