Is your software fit for regulation under the MDR?

In six months from now, the MDR (Medical Device Regulation) will be here. Everyone is waiting for crucial updates such as

  • the new EUDAMED in which devices and manufacturers need to be registered,

  • updates on harmonized standards and

  • which Notified Bodies will be able to certify your medical device?

We wrote before about the impact of the MDR on software classification, but this is not the only aspect of software for which the MDR is important.

Software is becoming increasingly important in the healthcare industry. This is as well recognized by the Regulators.

When you compare the number of times the word software appears in the Medical Device Directive vs the MDR, there is almost an 8-fold increase.

The main changes are in the: 

  • Classification: more software is considered a medical device and more software-based medical devices are in the higher risk classes.

  • Safety and Performance Requirements: specific mentioning of software as a medical device.

Not only Europe, but other countries/regions are focusing more and more on software as a medical device:

  • Australia: based on 2013 guidance by GHTF. In the TGA guidance of 2018 on software as a medical device, we can read: “The TGA recognizes that the existing regulatory framework for medical devices in Australia may not be well structured to address the potential public health risks posed by SaMD products. Therefore, the TGA is currently reviewing the regulatory framework for SaMD in Australia. Part of that is seeing where we can harmonise with the published IMDRF technical documents for SaMD.”

  • FDA: software is regulated under 21 CFR but FDA keeps working on additions/improvements. All based on the work of IMDRF (chaired by FDA). E.g. a new guidance was issued on clinical evaluations of SaMD at the end of 2017 

  • China: In August 2015, 2015 Order No 50 “Principle of technical review of medical device software” was released to specify in more detail the requirements for medical device software

  • India: Revised its entire medical device regulation in 2017. Includes software now as well

  • Japan: revised in 2014 to include software

We recently gave a presentation at the Biolago Academy regarding this topic:

Taking into account the changing legislation and the differences between them, it becomes more and more difficult to manage all requirements on paper.

Therefore, it's worthwhile to look for other solutions like an Application LIfecycle Management solution. A tool that allows you to map requirements from different legislation with your own documentation.


If you have any questions or would like to try out our software, don't hesitate to visit our website or contact us directly.

About the Author
Ann Vankrunkelsven
RA/QA Manager