ANSWERED ON THIS PAGE:
- Do you need to select an Authorized Representative for clinical trials in the EU?
- What services does the Authorized Representative provide?
- What makes Emergo by UL ideally qualified to represent your company in Europe?
Manufacturers of medical and in vitro diagnostic (IVD) devices based outside the European Union are required by law to designate an Authorized Representative in order to carry out clinical studies within Europe. This position was previously established as part of EU regulatory practice for medical devices, but its definition and role has been further elaborated under the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). MDR defines an Authorized Representative as “any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.”
The role of the Authorized Representative in EU clinical trials
Our clinical research team specializes in pre- and post-market clinical studies for medical devices. These studies are critically important for ensuring that your device functions in a safe and effective manner while fulfilling its intended use. MDR and IVDR have placed particular emphasis on the importance of conducting clinical trials and publishing clinical data with full transparency. If your company is interested in accessing the European market, clinical studies conducted in Europe are likely to bear more weight than those performed in locations such as the US or Australia.
As your Authorized Representative for clinical studies in Europe, Emergo by UL is prepared to provide authorization for the use of Emergo by UL’s name and registered address. To do so we will assess, amongst others:
- Documentation to be submitted to Local Authorities, including Clinical Study Protocol, Investigator Brochure, Risk Assessment, and information supporting the device’s safety and efficacy.
- Documentation addressed to the relevant Ethics Committees or Board.
- Authority/EC communication associated with the approval of the respective study.
Our clinical research team is also prepared to assist you with additional study activities such as:
- Notification(s) to Local Authorities.
- Reportable events—Serious Adverse Device Effects (SADEs) and device deficiencies—including assessments of how severe events are and whether they are reportable.
Why choose Emergo by UL to provide in-country representation for medical device clinical trials in Europe?
Because we work exclusively with medical devices, we have accumulated decades of expertise focused on European requirements. If, following clinical trials, you decide to go to market with a device in Europe, Emergo by UL Solutions can continue to serve as your Authorized Representative and liaise between your company and your national Competent Authorities.