Is your software considered a medical device under the EU MDR/IVDR?

March 25, 2021
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In March 2021 the European Commission released an infographic to assist manufacturers in determining whether their software qualifies as Medical Device Software (MDSW).

The EU MDR definition of MDSW is “software that is intended to be used, alone or in combination, for a purpose as specified
in the definition of a “medical device” in the MDR and IVDR”. Software that meets the MDSW qualifications is subject to the UDI labeling and database submission requirements.

To view the infographic on MDSW qualifications click here.

To learn more about HIBCC and UDI, visit or contact HIBCC directly at or +1 (602) 381-1091.