Under the cur­rent leg­is­la­tion, the Euro­pean Autho­rized Rep­re­sen­ta­tive is assigned a piv­otal role in the CE Mark­ing process of med­ical devices. If you are locat­ed out­side the Union and don’t have one, you can sim­ply not sell your prod­ucts with­in the Euro­pean Union. We can assist you dur­ing the process of under­stand­ing the cor­re­spond­ing obligations.

Euro­pean Autho­rized Rep­re­sen­ta­tive under the MDR / IVDR

The Euro­pean med­ical devices leg­is­la­tion stip­u­lates the role of a Euro­pean Autho­rized Rep­re­sen­ta­tive, also known as EU Auth. Rep., EC Rep or AR, for man­u­fac­tur­ers who don’t have their own loca­tion in Europe. EU Autho­rized Rep­re­sen­ta­tives act on behalf of man­u­fac­tur­ers to assume, among oth­ers, com­mu­ni­ca­tion with com­pe­tent authorities. 

Under the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­lataion (EU) 2017/746 (IVDR), the EU Autho­rized Rep­re­sen­ta­tive is assigned a nar­row­ly defined role with the belong­ing obligations. 

As per def­i­n­i­tion “‘autho­rised rep­re­sen­ta­tive’ means any nat­ur­al or legal per­son estab­lished with­in the Union who has received and accept­ed a writ­ten man­date from a man­u­fac­tur­er, locat­ed out­side the Union, to act on the manufacturer’s behalf in rela­tion to spec­i­fied tasks with regard to the latter’s obligations […]”.


How you find cor­re­spond­ing infor­ma­tion about EU Autho­rized Rep­re­sen­ta­tion on mdi-Europa.com