Europe – Medical device clinical studies with medical devices and Brexit: Sponsors may suddenly become non-EU

The departure of the United Kingdom from the European Union on January 1st, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and study subjects (patients) may find themselves on different sides of a new EU outer border. Where the single market relies on one set of rules, different rules will apply for different markets–newly defined in the EU and UK as of January 1st, 2020.

Studies performed in the EU with UK-based sponsors

The EU has a clear set of rules to protect its citizens in case of clinical studies on or with humans. Those rules cover studies done by EU-based sponsors as well as non-EU sponsors, with one difference: The non-EU sponsor must appoint an EU-based Authorized Representative (in case of a study falling under the current Medical Device Directives) or legal representative (in case of a study falling under the new Medical Devices Regulation (MDR) or In-vitro Diagnostic Medical Devices Regulation (IVDR)). This EU representative will be responsible for the sponsor’s obligations. Studies started under the current EU Directives can keep relying on an Authorized Representative and do not need to switch to a legal representative on the MDR’s date of application on May 26th, 2021. There are differences between the Authorized Representative and the legal representative; the Authorized Representative is mainly responsible for notifications, whereas the legal representative, to our understanding, manages the sponsor’s compliance…