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Custom-made device exemption

The custom-made device exemption​

Custom-made devices are exempt from the standard Schedule 3 conformity assessment procedures (Annexes I–VII for general devices) — they do not need UKAB involvement and do not bear the UKCA mark.

Instead, the manufacturer prepares a statement (Annex VIII equivalent) confirming conformity with the applicable Essential Requirements and the prescription details. See Custom-made devices for full details.

The limits of the exemption​

The custom-made device exemption applies only to devices that:

  • Are manufactured to a written prescription
  • Are for a specific named patient
  • Are not mass-produced

Mass-produced devices — even if selected and adapted for individual patients — are not custom-made devices and cannot use this exemption.

Essential Requirements still apply​

The exemption is from the conformity assessment procedure — not from the Essential Requirements themselves. Custom-made device manufacturers must still:

  • Meet all applicable Essential Requirements
  • Maintain a QMS
  • Conduct risk management
  • Provide appropriate IFU
  • Maintain records
  • Register with MHRA as a manufacturer

Official references​

ReferenceDescription
UK MDR 2002, Regulation 3Custom-made device definition and provisions
UK MDR 2002, Schedule 3, Annex VIIICustom-made device statement