Guidance

Devices which incorporate an ancillary medicinal substance

Guidance for notified bodies: devices which incorporate an ancillary medicinal substance

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This Guidance is for Notified Bodies and their client companies wishing to consult the Medicines and Healthcare products Regulatory Agency (MHRA) with regard to the ancillary medicinal substance incorporated in a medical device.

Published 13 May 2016
Last updated 6 October 2017 + show all updates
  1. Updated attachment
  2. First published.