EC Releases Guidance on Qualifying Software Under MDR, IVDR

The European Commission released guidance on qualifying software under the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Software must have a medical purpose of its own to be qualified as medical device software (MDSW). Just as with any device, the intended purpose of the software is relevant for the qualification and classification of the software.

In order to be qualified as medical device software, the product must first fulfill the definition of software according to Article 2(1) of the MDR. To be qualified as in vitro diagnostic medical device software, the product must also fulfill the definition of an IVD according to Article 2(2) of the IVDR.

The guidance clarifies that software can directly control a medical device (as in radiotherapy treatment software), it can provide immediate decision-triggering information (as in blood glucose meter software), or it can provide support for healthcare professionals (as in ECG interpretation software).

“It is important to clarify that not all software used within healthcare is qualified as a medical device. For example, ‘simple search,’ which refers to the retrieval of records by matching record metadata against record search criteria or to the retrieval of information does not qualify as medical device software,” the Commission says.

Software that alters the representation of data for a medical purpose would qualify as medical device software — such as searching images to support a diagnosis or evolution of therapy, or software that locally amplifies the contrast of the finding on an image display.

Software that alters the representation of data for cosmetic or compatibility purposes does not qualify as medical device software. The guidance includes a decision tree for determining if software qualifies as MDSW or IVD software.

Read the guidance here: www.fdanews.com/10-25-19-Guidance.pdf.