IEC 62304 vs. IMDRF SaMD Guideline Risk Class

[WimVr]

Looking for some ideas and writing off some frustration.

One of the main issues during the implementation and working with the IEC 62304 is the risk classification of the medical device software. I'm speaking here from a standalone software view point, but integrated software will probably have the same issues. When is someone a class A, B or C. What is serious vs non serious injury and how can you interpret no injury is possible.

The moment IMDRF came with their draft guidance about SaMD clarifying what serious and non serious injury and their matrix between the guidance, 62304 and other regulatory documents, me and probably a lot of other QARA, R&D people danced in joy and happyness.

Then the dark day came that in the final version, all the usefuf parts of the imdrf were removed and you have now another risk classification, which no one will probably use and no one knows what to use it for.

Does anyone here has an idea if you can still link imdrf guidance to iec 62304? Or what is the idea behind the classification in the imdrf guidance

 

[Marcelo]

Re: IEC 62304 vs IMDRF SaMD guideline risk class

The IMDRF framework (and related levels) has nothing to do with 62304 and even other regulatory requirements.

It?s not another risk classification. It?s to be used as a basis to create or vise a risk classification.

 

[WimVr]

Re: IEC 62304 vs IMDRF SaMD guideline risk class

Thanks for the quick reply, that was what I was afraid for.

I hope the next revision of IEC 62304 will maybe add another risk class, the difference between class A and B is really huge at this moment. It would be nice to have B split up depending on the intended use of the device.

 

[Marcelo]

Re: IEC 62304 vs IMDRF SaMD guideline risk class

I hope the next revision of IEC 62304 will maybe add another risk class, the difference between class A and B is really huge at this moment. It would be nice to have B split up depending on the intended use of the device.

The amendment that JWG 1 will publish in a while does not change that, but it does provide a revised text to make the classification more clear.

The draft that we have right now of the next version (ed 2) also do not change the classification.

 

[kreid]

Have you thought of using the definitions in ISO14971?

Common terms Possible description​

Significant Death or loss of function or structure
Moderate Reversible or minor injury​

Negligible Will not cause injury or will injure slightly

They are given only as examples but might be fit for your purpose?

 

[swathi.sp]

Hi all,

Can anyone please let me know the difference between Software Development Life cycle(SDLC), Software System Life Cycle (SSLC), Software Product Life cycle (SPLC) in the below IMDRF reference

IMDRF/SaMD WG/N23, Final 2015

Thanks & Regards
Swathi SP