Annex VIII(3.5) says, "If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply."
I recommend that you list every rule, paragraph, and sub-rule (the indents) that apply. Then use section 3.5 to determine the final device classification.
For example, looking at Rule 4, there are multiple ways to get a Class IIa device:
Rule 4, Paragraph 1, Indent 3
Rule 4, Paragraph 1, Indent 4
Were an issue to arise later, it would be great to know the specific path to the classification.
Looking at Rule 7, it applies to short-term surgically invasive devices.
Rule 7, Paragraph 1, no indents apply
Looking at Rule 13 the path is Rule 13, Paragraph 1, no indents apply which leads to Class I.
I would list both rules, then describe your application of section 3.5.
Notice that Annex II(1.1)(f) requires the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII. I believe an adequate justification will include all the possible rules, in detail, as well as the section 3.5 application.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 18-Sep-2019 10:30
From: Allyson Swartz
Subject: EU MDR Classification Rules
Hello,
If multiple classification rules from EU MDR Annex VIII apply to a device, should we identify all rules? I know that the Annex states the highest classification applies if multiple rules or sub-rules apply to the device, but should the applicable rules be identified?
For example - we have a product that may be used in a non-invasive environment that may touch injured skin (Rule 4, resulting in Class IIa) but it also may be used in a minimally invasive environment for short term use (Rule 5, resulting in Class IIa). On my D of C, would I identify both rules as being applicable, ultimately with the Class IIa classification? Or would I only identify Rule 5 since it appears to be the most "worst case"?
Another example is an active device that can be used surgically but none of the specific active device rules or special rules apply. So a product may have Rule 7 apply (Class IIa) and it is active so Rule 13 would apply. Ultimately the classification is IIa, but should we list both rules?
Thanks in advance for any guidance on this!
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Allyson Swartz
Quality Engineer II
Coralville IA
United States
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