Definition Variant - Definition within Medical Device Directive

T

temujin

Dear Forum,

The Medical Device Directive states in e.g. Annex VIII, 3 that:
The technical documentation (...) must include in particular:
- a general description of the product, including any variants planned,

However, I cannot find any definition, or consensus statement regarding what is a variant, i.e. how much can you change a device before it becomes a completely different system?

Does anyone have any official guidelines regarding this?


regards
t.
 

Marcelo

Inactive Registered Visitor
Re: Definition of "Variant" within Medical Device Directive

However, I cannot find any definition, or consensus statement regarding what is a variant, i.e. how much can you change a device before it becomes a completely different system

Variants are not completely different systems, but a single medical device with different configurations. One example (from this document - Recommendation NB-MED/2.5.1/Rec5 - Technical Documentation) is "a group of catheters of a particular type differing only in length".

There´s also an Australian Medical Devices Guidance Document (not directly applicable to CE marking but the concept is the same) "Variants for Class III and AIMD Medical Devices" which have better explanations and examples.
 
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