|
Follow us on  |
| Prototype devices |
It is recognized that a manufacturer may wish to submit a small number of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production. |
The European Medicines Agency (EMA) is consulting on a new International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document on good clinical practice (GCP). The aim of the guidance is to provide a unified standard for the European Union, Japan and the United States so that there is consistency around clinical data requirements in these regions.