The EU medical device directives (Medical Device Directive 93/42/EEC, Active Implantable Medical Device Directive 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EEC) all require the designation of an Authorized Representative for the European Economic Area.

New Requirement for Clinical Trials on Medicinal Products

Directive 2001/20/EC which came into force on May 1, 2004, requires that sponsors of clinical trials on medicinal products located outside the EEA designate a “legal representative” established in the Community.
This new requirement is meant to ensure that the sponsor’s legal liability with regard to clinical trials conducted in the Community is enforceable via a third party located within the Community.
The “legal representative” in this Directive fulfils a role similar to the Authorized Representative in the other EC Directives relating to medical devices. In particular, the “Legal Representative” for medicinal product clinical trials should have the ability to represent the legal liability of the sponsor.
MedPass International Ltd holds comprehensive liability insurance in order to fulfil its responsibilities as Authorized Representative.