Regulation of IVDs for self-testing
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices and Patient safety
- First published:
- 3 July 2012
Guidance for notified bodies on the regulation of IVDs for self-testing.
PDF, 85.5KB, 13 pages
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This Medicines and Healthcare products Regulatory Agency (MHRA) guidance for notified bodies covers:
- lay studies for self-test devices
- labelling requirements for self-test IVD devices
- information on the instructions for use
- conformity assessment routes for self-test devices
Published: 3 July 2012