Responsibilities of EU AR
European Union Authorised Representative is your one stop solution for launching your medical device onto the European Market.
An EU AR has the following responsibilities:
- 1. Register the device with the National Competent Authorities (NCA) before the product is marketed.
- 2. Maintain all current technical files required for inspection by the European Authorities.
- 3. Always act as your medical device’s primary point of contact and state the EU AR’s Name and Contact details on product packaging and associated documentation.
- 4. Reporting to the competent authorities about incident and Field Safety Corrective Action (FSCA), in coordination with your distributors.
- 5. Maintain detailed reports of clinical trials and advise the company about the latest and relevant regulations which can affect the product.
- 6. In case the product needs to be withdrawn from member states, the EU AR will represent the company to the European Commission.
- 7. Carry out necessary post-market surveillance and report to the Competent Authorities about any incident.
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