Software Now under the Scope of the IVDR

Software requirements are already mentioned in the IVDD, although in a general way and limited to trisomy 21. A search for the term illustrates the relevance of software today: whereas there were only four hits in the IVDD, there are now 50 in the IVDR. The IVDR finally gives software the importance it has long deserved:

""in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, 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 on one or more of the following (...)"

The term medical device software covers numerous devices that are applied in a therapeutic or diagnostic context; against the background of digitization in health care, their importance is increasing significantly. Primarily it refers to software IN medical devices, also referred to as embedded software, but also to software AS a medical device, so-called stand-alone software.

Manufacturers of medical devices and in vitro diagnostic medical devices are faced with the challenge to develop cost-efficient products of high quality that comply with the regulations. Both IVDR and MDR require manufacturers to ensure their devices’ safety and the expectations of software documentation are also high. Especially small and medium-sized businesses often experience a lack of resources and insufficient knowledge of general regulatory requirements.

As your holistic service provider we guide you through all stages of your devices’ software life cycle – competent and reliable.