3 Notifications about interventional procedures

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3.1 Sources and timing of notifications

Clinicians and healthcare professionals are the main notifiers to NICE about interventional procedures. However, anyone may notify NICE about a procedure for consideration. Notifications to the programme are made using the notification form on NICE's website.

Non‑clinical NHS staff wanting to notify NICE about a procedure are encouraged to discuss it with a clinician first because completion of the notification form is improved by clinical knowledge of the procedure.

Medical technology companies are encouraged to read the 'Prioritising our guidance topics' page for information on how to notify an interventional procedure to NICE and register their product on the NHS Innovation Service.

Professional organisations, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme and other organisations may also notify NICE about interventional procedures that are being done in the NHS outside a formal research setting, or about those that clinicians are considering doing.

Members of the NICE team may identify new procedures, usually when investigating notified procedures. The team sometimes approaches professional organisations to invite them to notify procedures that have been identified in this way.

It is appropriate to notify NICE about an interventional procedure if:

it is novel, with an unknown or uncertain efficacy and/or safety profile, or
it is a variation of an established procedure that may have a different efficacy and/or safety profile from that of the established procedure.

Anyone can contact the NICE team for advice on whether it is appropriate for a procedure to be notified.

Sometimes practitioners make minor alterations to established procedures and these do not merit notification, for example a small change in the length or site of an incision to improve access in an operation.

Clinicians doing a well-established procedure for the first time should not notify it to NICE.

While guidance is in development, clinicians wishing to carry out the procedure, and their trusts, should ensure that additional arrangements are in place for consent, governance, audit and research.

3.2 Notifications from the MHRA

The MHRA has the statutory function of monitoring serious device‑related adverse events. If the MHRA gets reports of serious concerns about the safety of a procedure or device, it can notify the procedure to NICE. This will prompt NICE to consider assessing the procedure or, if interventional procedures guidance has already been published, updating this guidance.

3.3 On receipt of notifications

When NICE is notified of a procedure, it determines whether it falls within the remit. Notifications are scrutinised by the NICE team, the chair and members of the committee, and others as needed, to establish key facts about the procedure that were unclear in the notification. For each notified procedure, the NICE team seeks advice from experts about the novelty of the procedure, its use in the UK and whether guidance from NICE would be helpful. If there are doubts about the suitability of a procedure for guidance, the final decision is made by the associate director.

3.4 Outcome of notifications

If a procedure falls within the remit, it is assessed (see section 2).

Details of all interventional procedures notified to the programme are available on NICE's website. The following information is given about each procedure within the programme's remit:

the name of the procedure
a procedure description
a description of current established practice, including other procedures used for the same purpose
the disease area
the clinical specialty or specialties of clinicians who might do the procedure
links to relevant documents produced by NICE (assessment report, consultation document, guidance, table of consultation comments including NICE's responses, external assessment group report for certain procedures, and information for the public)
links to relevant documents produced by other agencies, like the MHRA
links to related NICE technology appraisal guidance and NICE guidelines
notices about changes of status to a piece of interventional procedures guidance (for example, if the guidance has been withdrawn or replaced through incorporation into a NICE guideline).

The status of the procedure is shown on the NICE website.

If a notified procedure appears to fall within remit in all respects except that it is not yet being used in the NHS or independent healthcare sector, or there is no evidence base with which to assess it, it is monitored and assessed at a future date if circumstances change. Such procedures are listed on NICE's website, along with the reason why they are not yet being assessed.

If a procedure does not fall within the remit of the programme, it is not assessed. Notified procedures that are not within remit and the reasons for this are also listed on NICE's website.

Whether the procedure is within the remit or not, NICE informs the notifier of the procedure of the outcome of their notification.

If guidance production is paused or stopped before publication, published documents relating to NICE's assessment of the procedure remain on the website for a maximum of 6 months. After 6 months, if NICE is not going to publish guidance, the documents are removed.