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, if they sponsor a clinical study, are required by law to designate a Legal 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).
The role of the Legal 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 an important consideration.
As your Legal 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 and IVDs, 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 Legal Representative and liaise between your company and your national Competent Authorities.
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