With the IVDR (Regulation (EU) 2017/746) now fully in force, the European Association of Medical Devices Notified Bodies (Team-NB) has published an updated position paper aimed at resolving ongoing confusion around software qualification. For manufacturers developing or marketing software associated with in vitro diagnostic medical devices (IVDs), this guidance is a must-read.
The document outlines three critical qualification routes:
Importantly, the paper provides practical examples and a helpful decision tree (see page 4) to guide manufacturers in determining whether their software must be submitted to a Notified Body. It also underscores that approximately 80% of IVD software products now require formal assessment under the IVDR—up from a minority under the previous directive.
Manufacturers are reminded to pay close attention to their software's intended purpose, especially when it includes AI/ML components, diagnostic algorithms, or integrated clinical decision support. Tools like LIMS or middleware for image formatting may fall outside the IVDR’s scope but must still be carefully assessed.
At RQMIS, we assist clients in navigating these nuanced classifications, supporting robust justification and documentation to ensure regulatory success. For more information on software qualification strategy, reach out to our IVDR compliance team today.