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

Mr. Wern­er Sander
Quotes, con­tracts, gen­er­al con­sul­tan­cy
email: werner.sander@mdi-europa.com

Mr. Michael Sander
Spe­cial con­sul­tan­cy, author­i­ty con­tact per­son, tech­ni­cal doc­u­men­ta­tion
email: michael.sander@mdi-europa.com

Mr. Oliv­er Giese­mann
Gen­er­al con­sul­tan­cy, free sales cer­tifi­cates, device reg­is­tra­tions, qual­i­ty man­ag­er
email: oliver.giesemann@mdi-europa.com

Ms. Astrid Schmiedtke
Ms. Ingrid Sander
Ms. Sheila O’Shaughnessy

email: buchhaltung@mdi-europa.com

In Mem­o­ry Of

Mrs. Mar­ti­na Sander-Giese­mann
Co-founder of mdi Europa GmbH and Vice Pres­i­dent Oper­a­tion
*Sep­tem­ber 1974 – † June 2018

Mr. Michael Bain
Co-founder of mdi Europa GmbH and CEO
*Novem­ber 1955 – † Decem­ber 2009

Con­tact Details

mdi Europa GmbH
Lan­gen­hagen­er Str. 71
30855 Lan­gen­hagen

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