Software as Medical Device

For classification of the software to be a medical device, please see Rule 11 from Medical device regulation MDR 2017/745 here:

• EU MDR Annex 8 – Classification rules https://advisera.com/13485academy/mdr/classification-rules/

Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

death or an irreversible deterioration of a person’s state of health, in which case it is in class III; ora serious deterioration of a person’s state of health or surgical intervention, in which case it is classified as class IIb.Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

Manufacturers of a medical device must have implemented ISO 13485:2016.

More information about this standard you can find on the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Clause-by-clause explanation of ISO 13485:2016 - https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Free webinar on demand: A how-to guide for ISO 13485 implementation - https://advisera.com/13485academy/webinar/a-how-to-guide-for-iso-13485-implementation-free-webinar-on-demand/