Our previous email and blog post discussed the importance of preclinical studies to clinical trials. A vital step in the “benchtop to bedside” process model is the move from research and preclinical testing to “first-in-human” (FIH) studies. Trends have shown that numerous US-based medical device and IVD companies prefer to conduct their clinical studies in the EU. However, multiple steps must be taken before a company is able to begin performing clinical trials. One of the necessary actions that need to be taken involves the selection of an Authorized Representative for clinical trials.
Directive 2007/47/EC defines an Authorized Representative as “any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.” According to the Directive, the designation of an Authorized Representative is required if a non-EU manufacturer of medical devices plans on conducting trials in the EU. Any device presented at exhibitions or other forms of demonstrations that does not adhere to this Directive is unable to be marketed until it is considered compliant.
In order to act as an Authorized Representative for clinical trials, the company must hold an address within the EU and must be registered in their country as a business serving as an Authorized Representative. The name of the company (Authorized Representative), address and identification (Tax ID) are required information for competent authority submission forms. This information is also essential for device labels.
Once appointed, the Authorized Representative is required to notify the competent authority of the Member State in which the company is registered. The intention to carry out a clinical investigation and the trial end date must be reported, and a written report of the clinical investigation should be made available to the competent authority as well. It is vital for these statements to be submitted to the competent authority no less than 60 days before the commencement of the investigation.
Companies who are not US-based may choose to conduct their clinical trials in the US instead of the EU. Similar to the EU, you will find that the selection of a representative (US Agent) is also a necessity before you can begin your study in the US.
To read the next blog in this series, The Need for an Agent for Clinical Trials in the US,click here.
If you missed the first blog in this series, Insights for Clinical Management, you can view it here.