In the context of medical devices there are different classifications that should not be confused:
A product is a medical device if and only if it meets the definition of a medical device in accordance with the medical device directive or medical device regulation:
„Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
This definition has the following consequence:
Especially in software, there are always borderline cases.
Read our article on the classification of software as a medical device.
Any medical device (and any accessory) has to fulfill the regulatory requirements as laid down in the Medical Device Directive respectively Medical Device Regulation and the national laws e.g.:
The Medical Device Directive lists the classification rules in Appendix IX, which states that the medical products fall into one of the following classifications:
In our e-learning library you get to know the classification rules. The training videos also tell you, how the classification of medical products affects the available range of conformity assessment procedures.
The Medical Device Regulation sticks with these classes, however, the conformity assessment procedures slightly have been changed, as well as the classification criteria, in particular the software specific rule 11.
The IEC 62304 is a harmonized standard that also is recognized by the FDA. The IEC 62304 defines three software safety classes:
The software safety class determines the amount and granularity of required software documentation.
Read here more about software safety classes and levels of concern.