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?”

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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”

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”

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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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Lords Challenge Data Sharing and Emergency Powers in Short 4th Session of Medicines and Medical Devices Bill Committee

This is the fourth post 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] Another week, another Committee session in the House of Lords on the Medicines … Continue reading “Lords Challenge Data Sharing and Emergency Powers in Short 4th Session of Medicines and Medical Devices Bill Committee”

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Lords keep up pressure on Government over Medicines and Medical Devices Bill in 2nd & 3rd Committee Stage Sessions

This is the third post 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] In another busy week of Brexit-related Parliamentary business, two further Committee sessions took place in the House … Continue reading “Lords keep up pressure on Government over Medicines and Medical Devices Bill in 2nd & 3rd Committee Stage Sessions”

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Lords take Government to task over future of medicines and medical devices regulation: Part 2

This is the second 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 1 available here] In this post, which reports on the first session of the Lords Committee Stage for the Medicines and Medical … Continue reading “Lords take Government to task over future of medicines and medical devices regulation: Part 2”

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