www.fdanews.com/articles/185324-mrha-launches-new-online-service-for-medical-device-submissions
MRHA Launches New Online Service for Medical Device Submissions
January 22, 2018
The UK’s Medicines & Healthcare products Regulatory Agency launched a new one-stop online service for device firms, with a requirement to begin using internationally agreed descriptors.
All existing medical device registrations will remain valid, but the new online accounts, which began being rolled out last November, will receive new account reference numbers.
MHRA plans to complete the launch of all online accounts by the end of February.
Under the new system, customers have the ability to submit medical devices, including a greater number of in vitro diagnostic devices, in bulk for registration with a single fee, and can track the progress of their applications in real-time via updates sent at each stage, among other benefits.