Guidance

Parallel imports of medical devices

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 26 February 2019 — See all updates

This publication was withdrawn on 1 January 2021

This guidance was withdrawn on 1 January 2021.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.

Documents

Parallel imports of medical devices

HTML

Notification of parallel import of self-test IVDs

MS Word Document, 182 KB

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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 26 February 2019 + show all updates

1. 26 February 2019

   Added a link to new guidance on medical devices regulation in a no deal scenario.

2. 18 July 2016

   Updated links

3. 18 December 2014

   First published.