Circle of Influence
Providing the best care for our clients means partnering with businesses that extend our quality and regulatory experience and scope of services. These are businesses we trust to deliver the same level of value, service and skill to our clients as we do.
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 as defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the (Active Implantable) Medical Devices Directive 90/385/EEC and 93/42/EEC (AIMDD and MDD) and the In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD) for a wide range of companies – from start-ups to established corporations throughout the world. 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.