Legal Representative / European Authorized Representative
Who needs to appoint a Legal Representative / European Authorized Representative?
Sponsors of a clinical trial with pharmaceuticals who do not maintain an establishment within the EU need to appoint a Legal Representative (acc. EU Regulation 536/2014).
Sponsors of a clinical trial with medical devices who do not maintain an establishment within the EU need to appoint an European Authorized Representative (acc. EU Regulation 2017/745).or medical devices (acc. EU Regulation 2017/745).