The Medical Device Coordination Group (MDCG) has issued a new guidance document “to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR).” (MDCG 2021-27)
The guidance answers important questions, e.g. what determines whether a person acts as a distributor or importer. These are crucial aspects, which should be understood by all economic operators. For manufacturers it will be essential to understand the tasks and resulting obligations of their distribution network to establish appropriate agreements.
Source: European Commission