CE Marking for Manufacturers of Medical Devices since 2000
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.
Highly Valuable Content on Our Website
In our online library, you will find a collection of links to useful resources on the European medical devices legislation and associated topics, like guidance and legislation documents, factsheets, list of notified bodies, European authorities websites etc.
Regular Updates and Newsletter
Get monthly news updates on MDR, IVDR, Guidance Documents and other important topics on our website!
As our customer you will receive a monthly newsletter with more in depth information on EU Regulatory Affairs in addition.
In our Customers own Words
“We are having your guidance more than expected.”
S. Mittal · Mediplus (India) Ltd.