A pharmaceutical form of an active substance or placebo being tested, or used, as a reference in a clinical trial, including products already with a marketing authorisation but, for the purposes of the trial, used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form (SI 2004/1031).
Is my study a trial of an Investigational Medicinal Product (IMP)?
Click here for an algorithm that can help determine whether your study involves an IMP.
However you can also contact the Regulatory Compliance Team for confirmation via firstname.lastname@example.org
What is a Medical Device?
According to the Medical Devices Directive (MDD), a ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: