Back in Decem­ber 2021, the Med­ical Device Coor­di­na­tion Group (MDCG) issued its guid­ance doc­u­ment 2021-27, Ques­tions and Answers on Arti­cles 13 & 14 of Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746. The doc­u­ment lays focus on the ques­tions around importers and dis­trib­u­tors under the Med­ical Devices and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (MDR and IVDR). Two years lat­er the MDCG pub­lished revi­sion 1 of the doc­u­ment with new ques­tions and answers (Q&As).

MDCG 2021-27, rev. 1 adds fur­ther details and foot­notes to already includ­ed Q&As. How­ev­er, read­ers may also find insights on new top­ics. For exam­ple, Q&A 16 makes clear that the same nat­ur­al or legal per­son can be autho­rised rep­re­sen­ta­tive and importer for one device. In con­trast, Q&A 17 clar­i­fies that the same is not pos­si­ble for dis­trib­u­tors and importers.

Q&A 23 adds more details on how importers and dis­trib­u­tors may ful­fil their oblig­a­tions with regards to traceability. 

Source: MDCG 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website