Hello everyone,
I'm attempting to confirm a suspicion I have concerning the rule 3 (i) "
for human genetic testing".
This simplistic rule puts ALL genetic DNA / RNA tests whatever their intended use / methodology into the same class, ie Class C.
When you consult the other points of the rule 4, clearly the objective of the Class C is to cover significant risk assays.
For example :
(h) to be used in screening, diagnosis, or staging of cancer;
(k) for management of patients suffering from a life-threatening disease or condition;
(l) for screening for congenital disorders in the embryo or foetus;
etc etc
Of course there also exists other NGS tests which
do not have such significant risks in terms of patient health.
My question is has anyone encountered this point & successfully negotiated with their Notified Body that infact the term "genetic testing" is targets only significant risk assays, and that when there is no significant risk (ie the assay result does not fit into any of the other categories (ie points "a" to "m" of rule 3) then the manufacturer should be allowed to apply rule 6 => "Devices not covered by the above-mentioned classification rules are classified as class B."
As both Class B & C require implication of the Notified Body, its any interesting point to clarify... maybe at EU level, via future Borderline publications.
Hoping that the explication is sufficiently clear.. I'd be grateful if anyone has similar experiences / encounters / thoughts about this ?
Thanks
Tim
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Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
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