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MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41
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MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41
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MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

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  Post Number #1  
Old 3rd January 2018, 10:14 AM

Total Posts: 8
Please Help! MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

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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  Post Number #2  
Old 22nd January 2018, 02:10 PM

Total Posts: 1,158
Re: MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

(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.
Thanks to yodon for your informative Post and/or Attachment!
  Post Number #3  
Old 6th April 2018, 09:26 AM

Total Posts: 57
Re: MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

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.
Thanks to kreid for your informative Post and/or Attachment!
  Post Number #4  
Old 9th April 2018, 04:37 AM

Total Posts: 44
Re: MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

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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