This post provides an overview of the papers included in a Symposium in the current issue of Law, Technology, and Humans edited by the Everyday Cyborgs 2.0 team. In September 2022, we had our first in person Everyday Cyborgs workshop with the theme, “Visions of the Everyday Cyborg”. Participants contributed papers on a range of … Continue reading “Regulatory Futures and Medical Devices: Symposium for Law, Technology, and Humans Journal”
Category: Medical Device Regulations
The Future of Medical Devices Regulation in the UK? Plus Ça Change, Plus C’est la Même Chose
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”
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?”
The Medicines and Medical Devices Act 2021 & Uncertain Regulatory Futures
This piece was originally posted as a University of Birmingham Research Perspective “The final legislation, much like the Bill as originally introduced, does little to address the current unwieldy nature of the existing system of medicines and medical devices regulation.” The Act has the potential to significantly impact the regulation of medicines, veterinary medicines, and medical … Continue reading “The Medicines and Medical Devices Act 2021 & Uncertain Regulatory Futures”
Roll-back on Hard-won Amendments as the Medicines and Medical Devices Bill Goes Through Final Stages
This post looks at the final changes to the Medicines and Medical Devices Bill 2019-21 as it concludes its passage through Parliament. [Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here, Part VI available here, Part VII available here, Part VIII available here] The Medicines and Medical Devices Bill completed its … Continue reading “Roll-back on Hard-won Amendments as the Medicines and Medical Devices Bill Goes Through Final Stages”
Increased Scrutiny & Time-limited Powers Built into Medicines and Medical Devices Bill after Lords Report Stage & Third Reading
This is our eighth post looking at the passage of the Medicines and Medical Devices Bill 2019-21. [Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here, Part VI available here, Part VII available here] The Medicines and Medical Devices Bill was back in Parliament for the House of Lords Report … Continue reading “Increased Scrutiny & Time-limited Powers Built into Medicines and Medical Devices Bill after Lords Report Stage & Third Reading”
Lords Leave Many Issues Unresolved in Final Committee Sessions on the Medicines and Medical Devices Bill Part II: Northern Ireland Regulatory Divergence & Consultation Requirements
This is the seventh and final of our posts looking at the main points of contention at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20. [Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here, Part VI available here] This is the second … Continue reading “Lords Leave Many Issues Unresolved in Final Committee Sessions on the Medicines and Medical Devices Bill Part II: Northern Ireland Regulatory Divergence & Consultation Requirements”
Lords Leave Many Issues Unresolved in Final Committee Sessions on the Medicines and Medical Devices Bill Part I: Cumberlege Review Recommendations
This is the sixth of our posts looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20. [Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here] The final two sessions of the Lords … Continue reading “Lords Leave Many Issues Unresolved in Final Committee Sessions on the Medicines and Medical Devices Bill Part I: Cumberlege Review Recommendations”