Regulation of CDS Software

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 26^th 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 requirements.

In this white paper, we attempt to provide a general overview of the regulatory requirements for CDS software. The paper specifically addresses:

• 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.