Although new Medical Device Regulation (EU) 2017/745 – MDR is postponed for one year until the 26th May 2021, manufacturers are working to provide or update their software technical documentation to be compliant with MDR requirements. The first hurdle to overcame is to be sure that the software is a medical device. It is important to clarify that not all software used within healthcare is qualified as a medical device.
Medical device software (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 medical devices regulation Regulation (EU) 2017/745 – MDR, or in vitro diagnostic medical devices regulation Regulation (EU) 2017/746 – IVDR. Software must have a medical purpose on its own to be qualified as a medical device software.
However, software that does not meet the definition of a medical device or an in vitro diagnostic medical device but is intended by the manufacturer to be an accessory for a medical device, or an in vitro diagnostic medical device, falls respectively under the scope of the MDR or IVDR.
So, medical device software 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 or IVDR, regardless of whether the software is independent or driving or influencing the use of a medical device.
The Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR presents a decision questions tree to determine if the software is under the scope of the MDR / IVDR:
Is your software under development a MDSW? TDV can assess you defining the intended use of the MDSW and lead the design and development tasks to obtain the documentation needed for its certification (CE Mark).
For more information on MDSW please contact us.