Abstract
Objectives
To identify the potential opportunities and risks around future UK regulatory reform of medical devices.
Design
A mixed methods approach, comprising a rapid literature review, one-to-one, semi-structured interviews with key stakeholders, a multidisciplinary stakeholder workshop, and a post-workshop survey.
Setting
United Kingdom.
Participants
32 key stakeholders across the medical device sector were identified both from the public and private sectors.
Results
Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers. Recommendations were identified to mitigate risks, centred on harnessing broader cross-sector collaborations, promoting patient and public partnership, and maximizing international engagement.
Conclusions
The UK’s medical device sector is at a time-critical juncture to construct a regulatory framework to navigate its exit of Europe and respond to Europe's transition to new medical device regulations whilst also addressing the ongoing demand for rapid approval for new devices in response to the global pandemic. Investment, capacity-building, and international engagement will play a central role in mitigating risks and maximizing opportunities for medical device regulation.
To identify the potential opportunities and risks around future UK regulatory reform of medical devices.
Design
A mixed methods approach, comprising a rapid literature review, one-to-one, semi-structured interviews with key stakeholders, a multidisciplinary stakeholder workshop, and a post-workshop survey.
Setting
United Kingdom.
Participants
32 key stakeholders across the medical device sector were identified both from the public and private sectors.
Results
Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers. Recommendations were identified to mitigate risks, centred on harnessing broader cross-sector collaborations, promoting patient and public partnership, and maximizing international engagement.
Conclusions
The UK’s medical device sector is at a time-critical juncture to construct a regulatory framework to navigate its exit of Europe and respond to Europe's transition to new medical device regulations whilst also addressing the ongoing demand for rapid approval for new devices in response to the global pandemic. Investment, capacity-building, and international engagement will play a central role in mitigating risks and maximizing opportunities for medical device regulation.
| Original language | English |
|---|---|
| Pages (from-to) | 596-606 |
| Number of pages | 11 |
| Journal | Therapeutic Innovation & Regulatory Science (SPRINGER) |
| Volume | 56 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 13 Apr 2022 |
Bibliographical note
Funding Information:OLA receives funding from the NIHR Birmingham Biomedical Research Centre (BRC), NIHR Applied Research Centre (ARC), West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd, and Janssen Pharmaceuticals, Inc. OLA declares personal fees from Gilead Sciences Ltd, GlaxoSmithKline (GSK) and Merck outside the submitted work. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient-Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. MC has received personal fees from Astellas, Aparito Mltd, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centred Outcomes Research Institute (PCORI) outside the submitted work. AD is employed by University Hospitals Birmingham NHS Foundation Trust. He is also a Member of the Regulatory Horizons Council, Honorary Professor at University of Birmingham and Artificial Intelligence Theme Lead for the Birmingham Health Partners Centre for Regulatory Science and Innovation. His work undertaken on behalf of the Regulatory Horizons Council is funded by the Department for Business, Energy and Industrial Strategy. His research outside the submitted work is supported by grant funding from University Hospitals Birmingham NHSFT, NIHR HTA awards, the NIHR Biomedical Research Centre (Moorfields Eye Hospital NHSFT/University College London), Health Data Research UK, Medical Research Council and the Wellcome Trust. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care or the Department of Business, Energy and Industrial Strategy. Other authors declare no competing interests.
Funding Information:
This work was supported by Research England’s Quality-related Research (QR) Strategic Priorities Fund.
Funding Information:
The Regulatory Horizons Council is an independent committee that identifies the implications of technological innovation and provides the UK Government with impartial and expert advice on the regulatory reform required to support its rapid and safe introduction.
Publisher Copyright:
© 2022, The Author(s).
Keywords
- medical devices
- regulations
- in vitro diagnostics
- UKCA
- CE mark