tb3625

Starting to get Involved
#1
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.
 

yodon

Forum Moderator
Staff member
Moderator
#2
(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.
 

kreid

Quite Involved in Discussions
#3
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.
 

FoGia

Quite Involved in Discussions
#4
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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