The amount of health data used in patients’
diagnosis or treatment is growing beyond a manageable level for individual clinicians.
Clinical decision support (CDS) software can help to access and analyse these
data and thereby assist clinicians in decision-making. Rapid developments are observed in clinical practice for the use of CDS software. This raises an important question:
CDS software, like any other medical
technology, should be safe and efficient. In response to previous patient
safety breaches, new regulations for medical device (MDR) and in vitro
diagnostic medical device (IVDR) are being introduced from May 26th 2020 and 2022, respectively, in the European Union and
associated member states such as Norway.
In general, more stringent requirements
apply to medical device software manufacturers. Moreover, health institutions
developing medical device “in-house” such as CDS software, shall comply to new
In this white paper, we attempt to provide
a general overview of the regulatory requirements for CDS software. The paper specifically
- The applicability of MDR/IVDR
- The reclassification of
software to higher risk devices and the classification rules.
- The requirements that apply to
health institutions developing or using in-house CDS software
Finally, we discuss potential challenges
related to CDS software regulation, and we provide high level recommendations
for manufacturers and health institutions.