The European Union requires all foreign firms wishing to market medical products in the EU to appoint an Authorized Representative (AR) to be responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs. The AR will register the companies, which manufacture low-risk devices, with the Competent Authority in which the AR is located. The AR’s address must appear on the product label, or the outer packaging, or instructions for use.
MedicSense is affiliated with some of the most prominent ARs and can assist you in:
- Locating the appropriate Authorized Representative (AR) that accommodates your needs.
- Make the initial contact with the Authorized Representative (AR).
- Provide the Authorized Representative (AR) with all the relevant company’s Regulatory information needed.