U.S. Agent Representation Service
MDR (EU) 2017/745
MDD (EU) 93/42/EEC
IVDR (EU) 2017/746
IVDD (EU) 98/79/EC
Why do you need this service?
The U.S. Food and Drug Administration Agent (FDA) requires any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment
Responsibilities of the U.S. Agent
- Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
- Assisting FDA in scheduling inspections of the foreign establishment and
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment
Why appointing MDSS as your U.S. Agent?
With a quarter century of experience as a European Authorized Representative for Medical Device, IVDD, and Pharmaceutical Manufacturers, MDSS has the professional experience, knowledge, and drive to make certain acting as your U.S. Agent will lead to your success in the United States.
Our fully staffed office in the United States is capable of handling all your U.S. FDA needs, with the same efficiency, confidentiality, and speed as our offices in Europe and the United Kingdom.
Do not hesitate to contact us, so we can provide all the information necessary to show you why selecting MDSS as your U.S. Agent will be the right choice for your company.