Expanding clinical trials into the EU and UK creates new opportunities for sponsors but also brings complex data protection and legal requirements.

Under the EU Clinical Trials Regulation (CTR), sponsors without an EU establishment must appoint a clinical trial legal representative as part of the submission process. The same obligation applies to EU medical device and in vitro diagnostic device (IVD) performance studies conducted under the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).

In addition, organisations are typically required to appoint a Data Protection Representative (DPR) under the GDPR, with comparable requirements under UK clinical trial and data protection laws.

While both a legal representative and DPR are essential, they serve distinct purposes and are frequently misunderstood or treated as interchangeable.

Join experts from The DPO Centre and DLRC Group to understand how to remove friction from your application process and ensure both your legal and data protection framework is right first time. Hear directly from specialists with extensive experience advising sponsors across multi-jurisdictional trials.

Watch On Demand