Concerning a congenital abnormality

from Medical device stand-alone software including apps (including IVDMDs)

by The British Healthcare Trades Association

Investigation, replacement or modification of the anatomy or of a physiological process

Software that gives information about an acquired or inherited condition or disease from results generated by an IVD. Results may be quantitative or qualitative and can be entered manually by the user or automatically from the IVD.

Examples that may be devices include: • Apps and software that are intended for detecting and interpreting mutations in DNA • Apps and software that are intended for determining risk of trisomies

Indicative words and phrases:

DNA Genomics Data analysis Big Data Next Generation sequencing...

Concerning a congenital abnormality

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Investigation, replacement or modification of the anatomy or of a physiological process

Indicative words and phrases:

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Medical device stand-alone software including apps (including IVDMDs)