Anyone can ask us to consider a device, diagnostic or digital technology for NICE guidance or NICE advice.
Our Medical Technologies Evaluation Programme (MTEP) considers technologies that could offer substantial benefits to patients and the health and social care system over current practice.
Hear Justin's experience of getting his product evaluated by NICE
Our product went from being in 4 hospitals to 15 within 6 months of guidance publication. That was incredible.Justin Hall, Vice President at NeoTract
How do we select technologies?
A technology is likely to be selected if:
- it meets the eligibility criteria
- it offers substantial benefits to patients or the health and care system compared with current practice
- the benefits are supported by evidence
- developing guidance would mean faster and more consistent adoption of the technology.
Suitable for development
The technology must be suitable for development under one of our guidance programmes, and not currently in development.
A new or innovative technology
It must be a new technology, or an innovative modification of an existing technology, that will have benefits to the patient or the NHS when judged against comparators.
The technology has one of the following CE marks (or equivalent regulatory approval) or is expected to get one within 12 months:
- a medical device (under EC directive 2007/47/EC or 93/42/EEC)
- an active medical device (under EC directive 90/385/EEC)
- an active implantable medical device, (under EC directive 90/385/EEC)
- an in vitro diagnostic medical device (under EC directive 98/79/EC).
(The CE mark is a mandatory conformity mark for all products placed on the single market in the European Economic Area, including medical devices. The mark certifies that a product has met EU consumer safety, health or environmental requirements.)
The technology must also be available to the NHS, or have plans to be launched in the NHS.
Eligibility criteria (PDF)
The benefits of a technology should be:
- easily understood
- clearly described
- supported by evidence.
Market access support
Our Office for Market Access (OMA) offers bespoke services to pharmaceutical, medtech and diagnostics companies. We can:
- help you identify the most appropriate journey for your product through NICE
- provide support regarding our processes and methods
- offer engagement opportunities in relation to particular products, and as part of the Early Access to Medicines Scheme (PDF)
- broker multi-stakeholder safe harbour meetings between companies, NICE and other relevant players in the NHS landscape.
Types of guidance and advice
Notified medical technologies are usually developed as one of the following: