A key objective of the MHRA is to enable greater access to safe and effective products, and the timely introduction of innovative medical devices and technologies that benefit patients and the public.
We recognise that the field of novel technologies that applies to medical devices is rapidly developing, and to support this we established the Medical Devices Technologies Forum in 2008.
Building on this initiative, we have established a web page for new and emerging technologies for medical devices. The aim is to support the scientifically sound development of novel technologies and encourage research in innovation in medical devices.
We hope that this will encourage academic researchers, small and medium sized enterprises (SMEs) and larger companies, seeking to understand the impact of the medical devices directives on their novel technology, to engage in early dialogue with the Agency.
Scope
It is difficult to define what constitutes a novel or innovative technology. However, we are keen to discuss those products or technologies that are transformational or a step change, rather than products that are developed incrementally.
We would be particularly interested in discussing technology or products that could potentially challenge the current regulatory framework and this could be due to their novel technology, materials used or as a result of convergence of technology, whereby a technology that is established in other fields is applied to medical devices for the first time.
Areas of technology that are a current focus include regenerative medicine (other than advanced therapy medicinal products), nanotechnology, synthetic biology, pharmacogenomics and software as a medical device.
Advice form for new and emerging technologies 
(154Kb)
Contact
In the first instance a form with your details and a brief description of your technology and query should be sent to: mdtfsecretariat@mhra.gsi.gov.uk
