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”
Tag: Medical Device Regulations
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?”
Introducing Everyday Cyborgs 2.0
As technology increasingly blurs the boundaries between the biological and the synthetic, law struggles to keep up Increasing numbers of people worldwide rely on medical devices to help them to function. These devices range from the relatively simple, like hip replacements and aesthetic prostheses, to the complex, such as insulin pumps, pacemakers, and the total … Continue reading “Introducing Everyday Cyborgs 2.0”