Guidance

Parallel imports of medical devices

MHRA’s current view on parallel importing of medical devices under the EC medical devices directives.

Documents

Notification of parallel import of self-test IVDs

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Details

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
Published 18 December 2014
Last updated 18 July 2016 + show all updates
  1. Updated links
  2. First published.