Regulatory
MIDI R1 regulatory information.
MIDI R1 is UKCA marked Class I Software as a Medical Device manufactured by King's College London.
UKCA Declaration of Conformity
The UKCA Declaration of Conformity identifies King's College London as manufacturer of MIDI R1 and declares the device under the manufacturer's sole responsibility.
MIDI R1 is self-certified as a Class I Software as a Medical Device.
- Product
- MIDI R1
- Manufacturer
- King's College London, Strand, London WC2R 2LS, United Kingdom
- Device type
- Radiological computer-aided triage and prioritisation software
- Device class
- Class I Software as a Medical Device
- GMDN code
- 44087 - Radiology Information System Application Software
- UKCA mark first affixed
- March 2026
- Declaration signed
- 13 March 2026 by Beverley Scott, Person Responsible for Regulatory Compliance, on behalf of King's College London.
- Applied standards and specifications
- BS EN ISO 13485:2016+A11-2021; BS EN IEC 62304:2006 + A1:2015; BS EN ISO 14971:2019+A11-2021; BS EN ISO 15233-1:2021; DCB0129:2018.