IVD Design and Manufacturing requirements

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

by The British Healthcare Trades Association

Concerning a congenital abnormality

In addition to the general requirements there are a series of specific design and manufacturing requirements. The manufacturer will need to determine which apply to their software by reviewing the details in Annex I of the IVDMDD.

1. Chemical and physical properties 2. Infection and microbial contamination 3. Manufacturing and environmental properties 4. Devices which are instruments or apparatus with a measuring Function 5. Protection against radiation 6. Requirements for medical devices connected to or equipped with an energy source 7. Requirements for devices for self-testing 8. Information supplied by the manufacturer

IVD Design and Manufacturing requirements

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