Validation and regulation


General guidance on new medical device regulations

An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR), MHRA.


NICE Evidence standards framework for digital health technologies

The National Institute for Health and Clinical Excellence (NICE) standards released in December 2018, set out the requirements needed to develop digital health technologies for the NHS. The standards will accelerate the uptake of products like healthcare apps and wearable devices across the NHS. The standards provide advice to digital health innovators about how the NHS makes decisions and about the standards of evidence they will be expected to produce for different types of digital technologies.

Digital technologies are emerging at a fast pace and the standards will help developers and investors understand what evidence is required to introduce their product for use in the NHS.

Working collaboratively NHS England, NICE, NHS Digital, MedCity, Public Health England and DigitalHealth.London have engaged with industry, commissioners and innovators to understand what is required for health technology to thrive in the UK. The resulting standards  support digital health technology development and provide guidance on what evidence is required when innovators present their products to NHS commissioners.

The NICE standards framework follows in the footsteps of a pioneering short report, Digital technology and evidence, by MedCity, Digital Health.London and BSI, which looks at whether there is a lack of guidance on how to generate the right evidence for faster and better uptake of digital health technology into the NHS and healthcare systems. It considered whether guidance is accessible for SMEs and lists the information and guidance sources that exist.


The DigitalHealth.London Evidence generator

The DigitalHealth.London Evidence Generator is a pan-London initiative established to support the evidence generation requirements of small and medium sized enterprises and other companies operating in the digital health arena. Sponsored by DigitalHealth.London, MedCity and the Health Innovation Network, it has been designed specifically to address the absence of a clear pathway for the generation of high quality evidence for these kinds of applications in real world settings.


National Institute for Health Research

The National Institute for Health Research (NIHR) funds health and care research and translates discoveries into practical products, treatments, devices and procedures. It works with charities and the life sciences industry to help patients gain earlier access to breakthrough treatments.


NIHR Office for Clinical Research Infrastructure (NOCRI)

NOCRI’s signposting service provides companies with access to a full range of experts who can collaborate on clinical research and help develop a potential therapeutic or technology. They can help companies identify and connect with experts who can help translate findings from basic science or new technology innovation into the clinical setting. This service offers companies:

  • rapid connections to NIHR experts and world-leading facilities
  • support to set-up collaborations between industry and NHS clinicians and academic partners
  • support to ensure these relationships are managed effectively.


NIHR Collaborations for Leadership in Applied Health Research and Care

The NIHR’s Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) are collaborations between local providers of NHS services and NHS commissioners, universities, other relevant local organisations and the relevant Academic Health Science Network. There are 13 NIHR CLAHRCs and their primary focus is on research targeted at chronic disease and public health interventions. Take a look at some of the evaluations on the projects.


Navigating the evidence gathering maze

NIHR, NOCRI, CLAHRCs? In this DigitalHealth.London podcast experts talk about the organisations that can help you get the evidence you need to back up your innovation.


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