Medical devices play an important role in enhancing patients’ quality of life and supporting the healthcare system. However, there is a need for improved methods of demonstrating their safety, performance and efficacy according to a report of a joint meeting by the Royal Academy of Engineering and the Academy of Medical Sciences.

The report, Establishing high-level evidence for the safety and efficacy of medical devices and systems, is based on a roundtable forum held on 16 January 2013 which brought together clinicians and engineers from healthcare, industry and academia along with funders and regulators.

A major theme is the potential to adopt methods from the engineering sector for assessing medical devices. The engineering framework for assessing safety has been built by dialogue between industry and regulators, and the development of a regulatory framework for medical devices would potentially benefit from a similar level of dialogue to establish hazards, safety functional requirements and thresholds. Dialogue between clinicians, device manufacturers and the ‘end user’ is also important to ensure that devices are designed to meet real clinical need.

The report discusses the value of observational studies where randomised controlled trials (RCTs) are not possible or appropriate. Devices, unlike medicines, are increasingly part of complex interventions where it is difficult to create a control group. However, these complex interventions are have a major impact on healthcare delivery and have the potential to offer considerable patient benefit. With appropriate design and guidance, meaningful trials for medical devices can and should be undertaken. Given its strong research base and with the NHS at the core of its healthcare system, the UK is well placed to generate the necessary high quality evidence for such devices.

The report is being launched today (19 June) at the Innovation in medical technologies event being held at the Royal Academy of Engineering. Professor Lionel Tarassenko CBE FREng FMedSci, who jointly Chaired the January roundtable alongside Professor Sir Alasdair Breckenridge CBE FRSE FMedSci and Professor Gus McGrouther FMedSci, will be outlining the themes of the report in the event’s keynote speech.

Professor Tarassenko, who chairs of the Royal Academy of Engineering's Panel for Biomedical Engineering, says:

"The design and testing of medical devices is a collaborative process between engineers and clinicians. Proper evaluation of safety, performance and efficacy is an essential part of this process, and the roundtable forum organised by the two academies provided an ideal opportunity for engineers and clinicians to learn from each other with a view to promoting best practice."

Sir Alasdair Breckenridge, Chair of the Medicines and Healthcare products Regulatory Agency, says:

"As medical devices become more complex, their regulation needs to keep up with the underlying science. The current devolved European regulatory systemrequires a drastic overhaul to reflect these changesand collaboration betweenengineers, clinicians and regulatorswill become even more important."

The report is part of the Royal Academy of Engineering and the Academy of Medical Sciences’ response to the European Commission’s current revision of the EU legislation on medical devices.

Notes for editors

  1. The report, Establishing high-level evidence for the safety and efficacy of medical devices and systems, is available:  Medical Devices and Systems (902.67 KB)
  2. Founded in 1976, The Royal Academy of Engineering promotes the engineering and technological welfare of the country. Our fellowship – comprising the UK’s most eminent engineers – provides the leadership and expertise for our activities, which focus on the relationships between engineering, technology, and the quality of life. As a national academy, we provide independent and impartial advice to Government; work to secure the next generation of engineers; and provide a voice for Britain’s engineering community.
  3. The Academy of Medical Sciences is the independent body in the UK representing the diversity of medical science. Our mission is to promote medical science and its translation into benefits for society. The Academy’s elected Fellows are the United Kingdom’s leading medical scientists from hospitals, academia, industry and the public service. We work with them to promote excellence, influence policy to improve health and wealth, nurture the next generation of medical researchers, link academia, industry and the NHS, seize international opportunities and encourage dialogue about the medical sciences:

For more information please contact

Philippa Shelton at The Royal Academy of Engineering Tel. 020 7766 0690; email: Philippa Shelton