Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

We have written our clinical evaluation work instructions to comply with MEDDEV 2.7/1 r4.

I'm now trying to figure out how IMDRF/SaMD WG/N41 fits in to all of this.

While the verbiage is different, it appears to refer to the same concepts. What I'm really struggling with is whether I must now require our medical device teams to write a definition statement and be labeled with another category.

The majority of our software devices are class II for FDA and class IIb for CE Mark.


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(Sorry for not replying sooner)

If you have software that is a stand-alone medical device, it is required to comply with the standards / regulations; one of which is the requirement for the clinical evaluation. (Bear in mind that the MDD / MDR is the regulation, the MEDDEV is guidance to help you comply, and IMDRF is just a group trying to help make sense of it all and push the industry in what they feel is the right direction).

You should end up with a Clinical Evaluation Report for your stand-alone software device that complies with the regulations.


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IMDRF/SaMD WG/N41 gives you the opportunity to include your software V&V as part of the evidence to justify that you e SaMD is clinically appropriate/valid.


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Isn't that the case for the MEDDEV as well? I know the wording could be more explicit but following the MEDDEV one can rely on pre-clinical testing to support a clinical evaluation.

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