This post discusses the Government’s response to the MHRA’s consultation on the future of medical device regulation. In October 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on proposed changes to the Medical Device Regulations 2002. As we have written previously, the consultation comes within a period of flux for medical … Continue reading “The Future of Medical Devices Regulation in the UK? Plus Ça Change, Plus C’est la Même Chose”
Category: Software as Medical Devices
AI/ML-enabled Medical Devices: Regulatory Discussion in the UK and the US
This post discusses the current regulation of AI/ML enabled medical devices in the UK and compares potential policy changes with the US. The emergence of Artificial Intelligence (AI) and Machine Learning (ML) systems in medical devices has been linked to improved healthcare – for example, by providing earlier and more accurate diagnoses to patients, automating … Continue reading “AI/ML-enabled Medical Devices: Regulatory Discussion in the UK and the US”
The Changing Face of Medical Devices Regulation? A Consultation & Expected New Regulations
This piece was originally posted as a Birmingham Law School Research Blog Post This post reflects on the potential reforms indicated by the recent MHRA consultation on the future of medical devices regulation In September 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation seeking views on potential amendments to medical devices … Continue reading “The Changing Face of Medical Devices Regulation? A Consultation & Expected New Regulations”
Software as a Medical Device: A Bad Regulatory Fit?
This post introduces some of the gaps and uncertainties we are exploring in relation to software as a medical device Advances in information technology have resulted in increasingly complex or “smart” medical devices that are capable of running software, lending these devices ever more complex functionalities. Often the relevant software comes as part and parcel … Continue reading “Software as a Medical Device: A Bad Regulatory Fit?”