Guidance

The IDAP Unmet Clinical Need Authorisation (UCNA)

Updated 19 June 2025

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This publication is available at https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-idap-unmet-clinical-need-authorisation-ucna

An Innovative Devices Access Pathway (IDAP) Unmet Clinical Need Authorisation (UCNA) allows non-UKCA or non-CE certified medical devices to be placed on the Great Britain (GB) market in the interest of the protection of public health.

The IDAP UCNA, which is based upon the principle of the Medicines and Healthcare products Regulatory Agency (MHRA) Exceptional Use Authorisation, is granted by the MHRA for a specified period and exempts the manufacturer from certain regulatory requirements. The MHRA reviews each UCNA application individually. The UCNA is subject to specific conditions and requires that the manufacturer demonstrate ongoing progress towards full conformity with the applicable regulations. The UCNA is not an alternative route to the UK market and is only applicable to products selected for the IDAP pilot.

Regulations 12(5), 26(3) and 39(2) of the Medical Device Regulations 2002 permit the Secretary of State to authorise the placing on the market, or putting into service, of non-UKCA or non-CE marked devices that have not undergone all of the necessary conformity assessment requirements. This power can only be exercised where the Secretary of State (acting through the MHRA) is satisfied that to do so would be in the interests of the protection of health.   

In addition, this authorisation can only be granted in certain situations, where the MHRA considers that the UCNA criteria are met and specifically that:

  • the technology addresses a critical unmet clinical need
  • there is sufficient data to show that the product is safe and potentially effective
  • there is evidence that the manufacturer is working towards regulatory approval or certification

The UCNA permits controlled access to a specified patient population and requires that manufacturer report safety and performance data to the MHRA in line with the authorisation conditions.

For the eight IDAP pilot technologies, manufacturers were able to request to supply their medical device prior to UKCA or CE marking as an exceptional use because there were limitations to other existing treatments available.      

The Unmet Clinical Need Authorisations were exclusively issued directly to the manufacturer of the medical device and only applied to devices supplied to the GB market.

There was one UCNA issued during the IDAP pilot:

HistoSonics Inc

EDISON™ SYSTEM AND ACCESSORIES

Issue date: 30 April 2025

Expiry date: 30 October 2025

MHRA reference number: IDAP/DEU/009/2024/0001

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