NICE medical technologies guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ recommendations are based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
Developing medical technologies guidance
Guidance considers a single medical device or diagnostic technology which provides equivalent or enhanced clinical outcomes for equivalent or reduced cost.
An overview of the development process:
Anyone can request NICE consider a medical technology for guidance by completing our notification form. NICE will assess whether a notified technology falls within the remit of the programme and meets the programme eligibility criteria.
The NICE technical team produce a briefing note on eligible technologies based on the notification form and information gathered from expert and patient advisers. The Medical Technologies Advisory Committee selects which technologies are suitable for guidance production and routes them to the relevant NICE guidance producing programme.
The scope defines the disease(s), the patients and the technology covered by the assessment and the questions it aims to answer. The draft scope is developed using the manufacturers' notification, opinion from Expert Advisers and patient organisations, and the Committee. The draft scope is made available for comment by registered stakeholders. The scope is then finalised taking into account comments from stakeholders and published on the nice website.
NICE invites manufacturer(s) to respond to the questions raised in the scope in their full submission which must be received by NICE in no more than six weeks (clinical evidence after two weeks, economic evidence within six weeks).
Assessment report prepared
NICE commissions an external assessment centre to independently review and critique the evidence on the technology and prepare an Assessment Report. The academic centres were chosen through public tender and have knowledge of and expertise in the evaluation of medical technologies.
- Birmingham and Brunel Consortium
- CEDAR - Cardiff and Vale university health board
- King's Imaging Technology Evaluation Centre
- Newcastle and York consortium - Newcastle upon Tyne hospitals NHS foundation trust
Medical Technologies Advisory Committee meeting
The MTAC is an independent advisory Committee which meets monthly, in public. It considers all the evidence presented and formulates draft recommendations.
Medical Technologies consultation document (MTCD) produced
The Advisory Committee makes its provisional recommendations in the MTCD. The MTCD is available on our website so that stakeholders, health professionals and members of the public can comment on it. Commentators have four weeks to comment on the MTCD.
Final guidance produced
The Committee considers the comments received on the MTCD then makes its final recommendations on the technology.
Once NICE's Guidance Executive has approved the final guidance, it is open to resolution, during which time individuals or organisations who commented on the draft guidance may request corrections to the guidance if they consider there has been a breach of process or there are factual errors.
If there are no resolution requests, NICE issues its final guidance to the NHS in England.
The process guide describes how NICE selects and produces its guidance on medical technologies. The methods guide describes principles and methods used to select and assess medical technologies.
The guides have been developed with substantial input from individuals and organisations within the NHS, the medical technologies industry, academia, patient and carer organisations and the Department of Health.
The Expert Adviser questionnaire issued to Expert Advisers who are nominated or ratified by their professional body.
The Patient and carer organisation questionnaire issued to patient and carer organisations who represent the groups of patients the technology is designed to impact upon.
The Sponsor's submission template contains both the clinical and economic evidence submitted to NICE and the External Assessment Centre.
The Patient and Carer organisation invitation to comment letter is sent to patient and carer organisations who represent the groups of patients the technology is designed to impact upon. It asks them to provide a written statement to NICE to help advise the Committee in developing its guidance.
The Assessment report template is completed by the external assessment centre after reviewing and critically evaluating the sponsor's submission.
If you would like to become a stakeholder in the development of medical technologies guidance, please complete and return the registration form.MT stakeholder registration form MS Word
NICE also publishes advice on new and innovative medical technologies as medtech innovation briefings. Information on these can be found at www.nice.org.uk/mib