The MDCG 2021-27 guideline provides clarifications relating to the 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). In particular, the document sets out details on the operational and practical implementation of Articles 13 and 14 and other related obligations on importers and distributors.
Recently, the document has been updated with further clarifications relating to issues such as:
Can the same person simultaneously cover multiple roles for a single device (agent and importer or distributor and importer)? Does a person who assembles a system or a procedural kit also assume the role of importer and distributor?
Furthermore, the guide has been enriched by guidance on logistics service providers and leasing companies.
Consulta la linea guida MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 December 2023