The European Union is one of the world's largest and most highly regulated medical device markets, serving over 500 million people and generating more than 150 billion euros annually.
Achieving MDR or IVDR compliance is essential, but it is only the first step. To legally place your device on the EU market you must also appoint a qualified EU based Authorised Representative.
Who we represent
- Medical devices under MDR 2017/745
- In vitro diagnostics under IVDR 2017/746
- Software as a Medical Device
- Startups and global manufacturers
With more than a third of global medtech revenue generated in Europe, the opportunity is substantial, and the representation requirement is not optional. Compliance Management Solutions provides responsive, fully compliant EU Authorised Representative services.
To discuss EU representation for your device, please contact our regulatory team.