MHRA’s current view on parallel importing of medical devices under the EC medical devices directives.
This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for parallel importers of medical devices. It helps to clarify the requirements of the European Commission (EC) medical devices directives and covers:
- when you are regarded as the manufacturer of a device
- your obligations as a parallel importer
- parallel importing of self-test in vitro diagnostic (IVD) devices