Technical File Guidance for Preclinical Evaluations

Ronen E

Problem Solver
Staff member
Moderator
#11
I was talking about the MDD, not the MDR. Please check mdd 93/42/eec amended by 2007/47/ec.
Oops, sorry. You are right. For some reason I had the pre-2007 amendment MDD in front of me.

Back to the discussion:

1.1d Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.
You need to address this clause as a whole. The adequacy of conformity demonstration is relevant only in cases where evaluation based on clinical data is not deemed appropriate. My reading of this clause concludes that this would be relevant only in very low risk devices, where it'd be quite obvious that clinical data is not necessary. I haven't checked MEDDEV 2.7.1 rev 4 in that context, but it might have something to clarify Annex X 1.1d (and perhaps support my thesis).

Back to your original question, you'd have to fully rely on performance / bench testing / pre-clinical evaluation results only if you are trying to avoid demonstrating ER conformity based on clinical data. Is that your situation?

Either way, regardless of Annex X contents, you have to demonstarate conformity with the ERs (typically in the ER checklist), and I assume you'd use anything relevant that you have to do so - performance evaluation results, bench testing results and any other - clinical or non-clinical - relevant results. If the data and analysis you have are adequate and the paper trail is traceable, I guess you should be fine. Anyway, I think that clause 1.1d doesn't really add much burden; it merely highlights the criticality of non-clinical data in establishing ER conformity where clinical data is not relied on (and not deemed necessary for that purpose).

Cheers,
Ronen.
 
Last edited:
Elsmar Forum Sponsor
#12
The proposed MDR makes things a little more clear:
Hi Marcelo,

Per new MDR 2017/745, clause 6.1 (a) Pre-clinical and clinical data:
1. does it mandate for all medical devices (from small hand held diagnostic devices to dialysis machines) to undergo animal test before clinical evaluation on human subjects?
2. What interpretation would notified body look for while assessment of the technical file, when it comes to animal test?
Example: a dialysis machine in India would have undergone simulated testing and next direct clinical evaluation on human subjects.
3. More over it may not be feasible and justifiable for smaller devices to undergo any animal testing.
Appreciate your insight.
 

Marcelo

Inactive Registered Visitor
#13
Hi Marcelo,

Per new MDR 2017/745, clause 6.1 (a) Pre-clinical and clinical data:
1. does it mandate for all medical devices (from small hand held diagnostic devices to dialysis machines) to undergo animal test before clinical evaluation on human subjects?
2. What interpretation would notified body look for while assessment of the technical file, when it comes to animal test?
Example: a dialysis machine in India would have undergone simulated testing and next direct clinical evaluation on human subjects.
3. More over it may not be feasible and justifiable for smaller devices to undergo any animal testing.
Appreciate your insight.
Hello, the regulations in general do not require specific testing (including animal testing), because it depends on the device, so the manufacturer designing the device need to device if animal tests are required.. For example, if you are designing an LAVD (artificial heart), it's common to test the feasibility of the prototype in animals before the clinical trials in humans.
 
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