If your company is a medical device manufacturer that exports its products to Europe you are required to establish an Authorised Representative in the European Union.
The EU Authorised Representative is the primary contact for the national Competent Authorities and the EU Commission. We have significant experience of working on behalf of clients all over the world as their EU Authorised Representative.
Why Do I Need An EU Authorised Representative?
The EU Medical Devices Directive states that non-EU medical device manufacturers need an EU Authorised Representative in Europe in order to be allowed to sell their products.
Why Use Acorn Regulatory?
- Register your medical device with the Competent Authorities and the EU Commission.
- Manage your technical documentation.
- Liaise with the Competent Authorities on your behalf.
- Manage Field Safety Corrective Action (FSCA) reporting in cooperation with your company and product distributors.
- Represent your company to the EU Commission.
- Handle the master file and make it available to the Competent Authorities on request.
Acorn Regulatory can help you to bring your new product to the European market or we can act as EU Authorised Representative for your existing products. Call us today on 00353 52 61 76706 or complete your details below and we will get back to you.