This document presents questions and answers on requirements related to 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 term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices. References to ‘the Regulations’ should be understood to cover both the MDR and IVDR.
The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. Activities described in Article 16 of the Regulations are covered in other guidance documents, including MDCG 2018-6 1 MDCG 2021-232 and MDCG 2021-263
Note: This document is non-exhaustive and should be read in conjunction with the MDR/IVDR. Of additional relevance are the Regulation (EU) 2019/1020 on market surveillance4 where applicable to the MDR and IVDR, the horizontal guidelines of the European Commission’s ‘Blue Guide’ based on the principles of the New Legislative Framework , and further complementary medical devices sectorial guidance documents
MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746