According to the current UK MDR 2002, an in vitro diagnostic medical device is
‘a medical device which
a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and
b) is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
i. concerning a physiological or pathological state
ii. concerning a congenital abnormality
iii. to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or
iv. to monitor therapeutic measures and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.’
Understand the devices Intended Purpose
The key question to start is: Does the output from the test have a medical purpose? This question differentiates the device from other non-medical tests, for example: tests used to check if you are driving while under the influence of drugs or alcohol, or what percentage of your genetic heritage comes from Iceland.
Specimen receptacles, intended for the containment and perseveration of specimens derived from the human body for the purposes of medical examination are also considered an IVD.
Some software including mobile apps, offer many different elements of testing, some parts of that application may have a medical objective, some may not. SO it is really important to understand which parts of the software come under the scope of the MDR2002. For more information on this, refer to the MHRA guidance on Medical devices: software applications (apps) – GOV.UK (www.gov.uk)
If the purpose of the device is not intended by the manufacturer to be an IVD device, then this could fall into ‘General Laboratory Use’ and would therefore sit outside of the MDR2002. However the limitations of the use of the device should be clearly stated on the label.
Reference: IVDD_legislation_guidance_-_PDF.pdf (publishing.service.gov.uk)