Parallel imports of medical devices
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Medical devices regulation and safety
- First published:
- 18 December 2014
- Last updated:
- 18 July 2016, see all updates
MHRA’s current view on parallel importing of medical devices under the EC medical devices directives.
MS Word Document, 182KB
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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
Updated: 18 July 2016
- Updated links
- First published.