The respon­si­bil­i­ties of an EU Autho­rized Rep­re­sen­ta­tive are defined in the Euro­pean leg­is­la­tion, but it is essen­tial to clear­ly stip­u­late the tasks your Autho­rized Rep­re­sen­ta­tive will assume on your behalf.

Duties and respon­si­bil­i­ties result from the defined role of an Autho­rized Representative 

Under the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR),

“‘autho­rized 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 […]”. 


mdi Europa will be your Euro­pean Reg­u­la­to­ry Affairs rep­re­sen­ta­tion. As such, we may be held respon­si­ble towards the EU com­pe­tent author­i­ties that you, the man­u­fac­tur­er, ful­fill all duties and respon­si­bil­i­ties as stip­u­lat­ed by the Regulations.

The EU author­i­ties will not cor­re­spond with non-Euro­pean man­u­fac­tur­ers direct­ly. All con­tacts will go via your Euro­pean Reg­u­la­to­ry Affairs Rep­re­sen­ta­tive, mdi Europa.

The EU author­i­ties will com­mon­ly not cor­re­spond with non-Euro­pean man­u­fac­tur­ers direct­ly. All con­tacts usu­al­ly go via your Euro­pean Reg­u­la­to­ry Affairs Rep­re­sen­ta­tive, mdi Europa.

The name and address of your Euro­pean Autho­rized Rep­re­sen­ta­tive must be shown on your label­ing, pack­ag­ing or instruc­tions for use. As a result, var­i­ous par­ties from all over Europe will con­tact us, when they have queries or ques­tions regard­ing your devices. This means, we will be in con­stant com­mu­ni­ca­tion with your dis­trib­u­tors, end-users, cus­tomers, etc.

Let experts on EU Reg­u­la­tions be at your service

mdi Europa will sup­port all nec­es­sary report­ing, reg­is­tra­tion and com­mu­ni­ca­tion with Euro­pean author­i­ties and bod­ies – to the right per­son at the right time, every time. Among oth­ers, the Reg­u­la­tions also require that the Euro­pean Autho­rized Rep­re­sen­ta­tive holds a copy of and ver­i­fies the man­u­fac­tur­ers Dec­la­ra­tion of Con­for­mi­ty and Tech­ni­cal File and ful­ly coop­er­ates with com­pe­tent author­i­ties and oth­er eco­nom­ic oper­a­tors when secu­ri­ty-rel­e­vant events occur.

The points above and oth­ers must be clear­ly defined in a for­mal man­date. Man­u­fac­tur­ers should also be aware that under the MDR and IVDR the EU Autho­rized Rep­re­sen­ta­tive becomes ful­ly liable for the manufacturer’s defect devices.

What you get on top

mdi Europa may assume a range of addi­tion­al ser­vices – please get in touch with us to find out more about us and our portfolio.

Inde­pen­dent­ly owned and oper­at­ed, mdi Europa ensures the elim­i­na­tion of every pos­si­ble con­flict of inter­est with regards to con­fi­den­tial trade or prod­uct infor­ma­tion. We guar­an­tee the high­est lev­el of pro­fes­sion­al con­fi­dence and cour­tesy at all times. This is con­firmed in our stan­dard ser­vice con­tract, or – at your request – by sign­ing a sep­a­rate con­fi­den­tial­i­ty agree­ment with you.

For fur­ther infor­ma­tion, please con­tact our team.