Interventional procedures programme manual

  • NICE process and methods
  • PMG28
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2 Remit for interventional procedures

NICE's remit for interventional procedures was set out by the Department of Health in 2003, in 'Health Services Circular 2003/11 – The interventional procedures programme: working with the National Institute for Clinical Excellence to promote safe clinical innovation'.

To fall within remit, a notified procedure must:

  • involve an incision, a puncture or entry into a body cavity, or use of ionising, electromagnetic or acoustic energy, and

  • be available within the NHS or independent sector, or be about to be used for the first time outside formal research, and

  • either not yet be generally considered established clinical practice, or

  • be an established clinical procedure, the efficacy or safety of which has been called into question by new information or advice and

  • have a UK Conformity Assessed (UKCA) or CE mark specific for the notified indication if a device is involved.

Procedures do not fall within remit if they are considered standard clinical practice with a sufficiently well-known efficacy and safety profile. All interventional procedures carry some risks. It is the extent of uncertainty surrounding the efficacy and safety of a procedure that NICE is concerned with. All decisions about whether procedures are in remit are recorded on NICE's website.

2.1 Procedures involving medical devices

NICE assesses procedures that involve a medical device if:

  • the procedure falls within remit, and

  • the device has at least 1 UKCA or CE mark device allowing it to be used for the purpose and indication for which the procedure is intended.

If a procedure involving a specific device is notified, the NICE team approaches the company or companies to ensure that at least 1 device has a UKCA or CE mark that is current and relevant to the proposed indication. NICE interventional procedures guidance does not name, or relate to, specific devices.

2.2 Other information about the remit

It is not within remit to evaluate the cost effectiveness of interventional procedures, or to advise the NHS on whether interventional procedures should be funded.