Please note this is an extract of the original bulletin.
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Page summary:
Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.
Change made:
First published.
MHRA and international partners publish five guiding principles for machine learning-enabled medical devices
Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.
Change made:
First published.
Software and Artificial Intelligence (AI) as a Medical Device
Page summary:
Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
Change made:
Added the MHRA, FDA and Health Canada’s 5 guiding principles for the use of PCCPs to the AI section.
The Innovative Devices Access Pathway (IDAP)
Page summary:
The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market.
Change made:
FAQs have been added throughout the IDAP guidance webpage.
