Regulatory agencies in the EU and US set the requirements for representation and also define a number of responsibilities for organizations acting on behalf of another company.
Levels of responsibility vary depending on the Regulatory Body responsible for the representative. However, based on responsibilities outlined for outside representation, the representatives are viewed as an extension of the company they act on behalf of.
Authorized Representatives must act as first point of contact with regulatory authorities and import/customs offices. When a device is entering the EU, the representative may need to be present at the port of entry to speak on behalf of the manufacturer. The Authorized Representative will need to prepare for audits by EU authorities, and create and manage a Device Master File; this will include declarations of conformity, technical documentation relevant to investigations being conducted, the manufacturer’s Quality Policy and incident reports and corrective actions.
When the manufacturer being represented is conducting clinical trials in the EU, a Trial Master File must also be developed by the Authorized Representative. If a clinical site is audited, the EU authorities may follow up by auditing the Authorized Representative as well as both the Device Master File and Trial Master File. In the occurrence of serious adverse events, it is the responsibility of the sponsor of the clinical investigation to report to the regulatory agencies; the sponsor could be either the manufacturer or the Authorized Representative.
On top of the responsibilities given by regulatory agencies, the manufacturer is also expected to delegate certain tasks to their identified representative. These tasks should be clearly written in the contract between the manufacturer and the Authorized Representative and should also be listed within the Device Master File and Trial Master File.
Compared to Authorized Representatives, US Agents have limited responsibility set by FDA. One of the major responsibilities a US Agent has is to maintain communication between the FDA and the non-US based company. Part of the communication involves the response to questions concerning the non-US based company’s devices that are imported or offered for import into the US. Unlike an Authorized Representative, a US Agent is not responsible for reporting adverse events to FDA. However, the US Agent must assist FDA when it comes to scheduling inspections of the non-US based company’s establishment. In the case that FDA is unable to reach the non-US based company, FDA may provide information or documents to the US Agent. This should be considered equivalent to providing the same information or documents to the non-US based company.
When deciding to perform clinical studies in another country, careful consideration must be given to selecting an ideal country and study site. Evaluating short- and long-term advantages are key to evading negative impacts to the execution and management of the study.
To read the next blog in the series, Conducting a Clinical Study in the US, click here.
If you missed the previous blog in the series, The Need for an Agent for Clinical Trials in the US, you can view it here.