Changing Indication of Use for a Class IIa Medical Device



Hi all,

We have a Class IIa medical device that received CE mark. The device approved for intended use A. and now the company would like to extend the scope to cover intended use A and B. This is done by adding a software module B into the original software. As for validating this software, we have conducted a small trial with 50 subjects and utilized the cross-validation method to teach to software to do data analysis and validate the software.

Does anyone know if such change will require a clinical trial? I know we will have to do a clinical evaluation, update the risk management file, and conduct software validation. Am I missing anything here?

Thank you in advance for every inputs! :D


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Once you perform the clinical evaluation and risk assessment, it should tell you whether you have sufficient data to support the new claims of safety and effectiveness.
As part of the clinical evaluation you'll have to apply certain criteria for the quality of the data (e.g. sufficient sample size, appropriate design, etc.), which need to be justified. Remember to use MEDDEV 2.7.1 rev 4.

Your 50-subject study may or may not be sufficient. Have a statistician look at it.

Ronen E

Problem Solver
I agree with mihzago.

In general, This can be seen as either an introduction of a new device (could be in the same device family), or a significant modification to an existing one. I recommend you take a careful look at your Design Control procedures and see what they say about determining which is the case, and what you should do under the applicable scenario (new / modified). You probably have some contractual obligations regarding notifying your NB, I recommend that you review that topic as well.

Good luck,
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