Requirements for SAMD

Classification of software is covered in the MDR by Rule 11.

"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; or
• a 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“

In my opinion, it is class IIb – because if the software is wrong, and the dental doctor receives the wrong picture, there can be conducted a wrong surgical intervention.

For software, the following requirements from the ISO 13485:2016 standard are definitely not applicable:

• 7.5.5 Particular requirements for sterile medical devices
• 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier systems
• 7.5.9.2 Particular requirements for implantable medical devices

Following requirements have to be taken into consideration:

• 7.5.3 Installation activities
• 7.5.4 Service activities

All requirements that are not applicable must be stated in the Quality manual with justification why those are not applicable.