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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”

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The Historical Geography of the Everyday Cyborg?

This post is the first in an occasional series building up a historical picture of the Everyday Cyborg One of the tasks currently being undertaken on the Everyday Cyborgs 2.0 project is to historicise the Everyday Cyborg. Some might disagree about how to define this central concept, and others might wonder whether there are better … Continue reading “The Historical Geography of the Everyday Cyborg?”

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Prescribing Unapproved Medical Devices? The Case of DIY Artificial Pancreas Systems

This post is a summary of our forthcoming paper in Medical Law International ‘Prescribing Unapproved Medical Devices? The Case of DIY Artificial Pancreas Systems’ Authors: Joseph T F Roberts, Victoria Moore, Muireann Quigley Healthcare technology innovation in type 1 diabetes (T1D) management has until recently been a relatively slow process. Tired of waiting for commercial manufacturers … Continue reading “Prescribing Unapproved Medical Devices? The Case of DIY Artificial Pancreas Systems”

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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”

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Prescribing and DIY Artificial Pancreas Systems

In this post we consider how clinicians can follow the standards set by the General Medical Council when making prescribing decisions for people who are using or considering using DIY APS. In DIY APS, each component of the system that a doctor is responsible for prescribing (insulin, CGM, and insulin pump) are appropriately licensed or … Continue reading “Prescribing and DIY Artificial Pancreas Systems”

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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”

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Now that we have commercial Artificial Pancreas Systems, is there still a place for DIY APS?

Dr Rachael Dickson explores whether advances in market authorised artificial pancreas systems spell the end of DIY APS and resolve the legal uncertainty that these systems raise. Over the last decade the #WeAreNotWaiting community has come together to develop DIY Artificial Pancreas Systems to help them manage their diabetes. Frustrated by the lack of commercial … Continue reading “Now that we have commercial Artificial Pancreas Systems, is there still a place for DIY APS?”

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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”

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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”

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Lords Discuss Prescribing Rights and Medical Device Innovation in Fifth Committee Session on the Medicines and Medical Devices Bill

This is the fifth 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]   The ever present issue of balancing … Continue reading “Lords Discuss Prescribing Rights and Medical Device Innovation in Fifth Committee Session on the Medicines and Medical Devices Bill”

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