Parallel imports of medical devices

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

This publication was withdrawn on

This guidance was withdrawn on 1 January 2021. This is because the UK has left the EU and is no longer part of the EU single market. You can read more about importer responsibilities in our guidance.


Notification of parallel import of self-test IVDs

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email Please tell us what format you need. It will help us if you say what assistive technology you use.


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 26 February 2019 + show all updates
  1. Added a link to new guidance on medical devices regulation in a no deal scenario.

  2. Updated links

  3. First published.