EU Autho­rized Rep­re­sen­ta­tive based in Germany

mdi Europa GmbH acts as Euro­pean Autho­rized Rep­re­sen­ta­tive, as defined in the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR).

CE Mark­ing Specialists

Our high­ly qual­i­fied reg­u­la­to­ry affairs spe­cial­ists pro­vide hands-on expe­ri­ence and have reg­is­tered hun­dreds of med­ical device man­u­fac­tur­ers for CE Mark­ing with the Euro­pean com­pe­tent authorities.

Reg­u­la­to­ry Experts network

We have cre­at­ed an inter­na­tion­al net­work of reg­u­la­to­ry experts, to pro­vide our clients with excel­lent ser­vices around the world. 

Flex­i­bil­i­ty, safe­ty and effi­cient pricing

We exact­ly know the chal­lenges and needs con­nect­ed to mar­ket entries as well as small and medi­um-sized enterprises. 

Due to our lean struc­ture, we not only safe­guard flex­i­bil­i­ty and effi­cient pric­ing, but also con­tin­u­ing reli­able guid­ance by one con­tact per­son through­out all processes.