MDCG guid­ance doc­u­ment on dis­trib­u­tors and importers published

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

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website 

• EU Autho­rized Rep­re­sen­ta­tive vs. Distributor
• Sup­port­ive Infor­ma­tion Sec­tion mdi Europa
• Stan­dard ISO 20417:2021 for the MDR and IVDR published
• EU clear­ance for MDR and IVDR har­monised standards
• mdi Europa expe­ri­ence on MDR tech­ni­cal doc­u­men­ta­tion reviews