If you manufacture a medical technology (including devices and diagnostics) you can ask us to consider it for guidance.
We'll compare it with technologies already available. In particular, we'll ask:
- does it offer substantial benefit to patients/NHS compared with current practice?
- is it likely to be adopted more consistently and more rapidly if guidance is developed?
To be recommended by us it needs to offer advantages over
- clearly described
- easily understood
- immediately plausible.
High-quality scientific evidence supporting these advantages increases the likelihood of a technology being selected for evaluation.
Information about costs (even indicative costs, in the first instance) is also useful to help us make judgements about selection.
How to notify us
You need to complete the notification form (PDF). But before you do, please contact us. We'll answer any questions you have about the process and we can arrange a meeting if you'd like to discuss things in more detail.
The information you provide on the notification form will be used in the briefing note that we prepare. The briefing note is presented to the advisory committee to help them make decisions.
When you complete your notification form
Check that your product meets the 3 eligibility criteria.
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)
Find out more
Use our resource planner to help you plan ahead and find out which technologies are scheduled for development.
Find out more about the medical technologies advisory committee, including:
- how to attend a meeting
- read papers from previous meetings.
Market access support
Our Office for Market Access (OMA) offers bespoke services to pharmaceutical,
- 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.