The growth of digital health, including artificial intelligence, software, and apps; combined with the implementation of the Medical Device Regulation (MDR) & In Vitro Diagnostics Regulation (IVDR), and the UK tech vision to build the most advanced health and care system in the world, all mean that it is an exciting time within the world of medical devices.
At the beginning of September, I started a secondment opportunity to change roles at MHRA and move over to our Devices Division to lead the Safety and Surveillance group and the Software and Apps group.
You may have seen that the MHRA has recently been successful in it’s bid to the Regulators Pioneer Fund, which was established to support bodies to create a regulatory environment that gives innovative businesses the confidence to invest, innovate and deploy emerging technologies for the benefit of consumers and the wider economy. At MHRA we will be taking forward a pilot project, in conjunction with NHS Digital, that is aimed at producing synthetic datasets which will help innovators validate software and apps to be able to bring them to market at the earliest, safest opportunity.
Within the Inspectorate, Dr Andrew Gray will be the Head of Inspectorate and Process Licencing and his previous role as Unit Manager, GCP, GLP, GPvP is currently in the process of being back filled.
I will be providing continuity for MHRA at PIC/S meetings by continuing as the MHRA representative and providing links back to the Inspectorate where software and apps, and combination products touch between the two divisions.
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