Classification Rationale for class 1

karena

Registered
We were told to develop a classification rationale for our class 1 non invasive medical devices that we did not feel were class 1 r . Does anyone have any sort of template to help write this?
 

KShaw

Involved In Discussions
Hi Karena,

I cannot really guide you towards a particular template, but what I would suggest is that you list the Rules for Annex VIII of the MDR in a table. Near each one, you identify which are applicable, and which are not, providing a rationale for each. You can obviously group many at once (e.g. you say it is not invasive, so rules 5-8 won't apply).

With respect to identifying whether it will qualify as 1r or not, again copy the definition of a reusable surgical instrument as provided in Annex VIII and provide your rationale as to why your product does not fit that definition.

If you haven't already, you're also supposed to provide a rationale as to why your product qualifies as a medical device under the MDR.

Hope this helps!
 

Highground

Involved In Discussions
This is the basic format we are using. It will give you an idea how to set the document up.

I need help on accessories that are classified as Class I for use with a system that is Class IIb which is approved under MDD until 2024. Do I have to classify the class I under MDR?
 

Attachments

  • Rule Number.docx
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KShaw

Involved In Discussions
Hi Highground,

If your products truly meet the definition of an accessory to a medical device, then they will be treated as a medical device in their own right. Furthermore, if they are not considered to be part of the Class IIb system (and thus have not been assessed by an NB) you would be expected to meet the MDR requirements for this Class I accessory and meet the MDR manufacturer's obligations. Just be careful of the 26 May 2021 deadline.
 
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