About mdi Europa

Who we are and why we might be exact­ly the right choice for your busi­ness goals

mdi Europa GmbH was found­ed in March 2000 to pro­vide med­ical device man­u­fac­tur­ers world-wide with flex­i­ble and well-adjust­ed ser­vice pack­ages to assist clients to com­ply with EU legislation.

mdi Europa GmbH acts as Euro­pean Autho­rized Rep­re­sen­ta­tive for a wide range of companies 

(As defined in the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR), the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR)) – from start-ups to estab­lished cor­po­ra­tions through­out the world.

Our high­ly qual­i­fied reg­u­la­to­ry affairs spe­cial­ists pro­vide hands-on experience 

They have reg­is­tered hun­dreds of med­ical device man­u­fac­tur­ers for CE Mark­ing with the Euro­pean com­pe­tent authorities.

We exact­ly know the chal­lenges and needs con­nect­ed to 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.

We have cre­at­ed a world-wide net­work of reg­u­la­to­ry experts 

This enables us to pro­vide our clients with excel­lent reg­u­la­to­ry ser­vices around the world. If you want to find out more, your are wel­come to read some words from our cus­tomers and net­work partners.

Our cus­tomers are

• man­u­fac­tur­ers
• importers
• exporters
• dis­trib­u­tors 

Our high qual­i­ty com­pli­ance solu­tions include

• clas­si­fi­ca­tion
• iden­ti­fi­ca­tion of EU standards
• Tech­ni­cal Doc­u­men­ta­tion com­pi­la­tion and review
• prod­uct reg­is­tra­tion to nation­al EU authorities
• label­ing compliance
• Free Sales Certificates
• mar­ket research
• trans­la­tion ser­vices and more

(as con­firmed by our ISO 9001:2015 certification)

Team mdi Europa

Con­tact Details

mdi Europa GmbH
Lan­gen­hagen­er Str. 71
30855 Lan­gen­hagen
Ger­many

Phone +49 511 39089530
email: info@mdi-europa.com