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Proposed revision of IEC 62304 - 2019

#1
To all

Dear fellow members would you like to read the attached document and put forward your views as there is much discussion as to the direction of IEC 62304 in the future.

The Netherlands is of the opinion that the current project to revise IEC 62304 needs reconsideration by the responsible committees, IEC/TC 62 (the lead committee) and ISO/TC 215.
The following arguments substantiate this opinion; each argument is elaborated on the following pages.
1. The current standard (Ed1.1) contains a fundamental flaw regarding risk management. This flaw hinders application in the regulatory domain and is
not addressed in the revision;
2. The material submitted to IEC and ISO for distribution as CDV/DIS does not represent state of the art;
3. The material submitted to IEC and ISO for distribution as CDV/DIS is not following the main principle to be “agnostic” to regulatory terminology;
4. The key part of the revision, broadening of the scope of the standard from “medical device software” to “health software”, is done in a manner that
precludes full use of the standard;
5. The risk classification imposed by the standard is not in line with regulatory classification of software products, including the IMDRF Risk Categorization
concepts;
6. The material submitted to IEC and ISO for distribution as CDV/DIS has elements of a product standard, whereas IEC 62304 is a process standard.
This makes implementation of the standard unnecessarily cumbersome and complicates referencing from true product standards;
7. The revision project team refused to address serious comments, even when submitted repeatedly.

If you have any contacts in Europe or elsewhere with voting rights on IEC 62304, I suggest you inform them of the dutch position (attached) and suggest that they kindly support it through their national organisation.

BR
PRP
 

Attachments

#2
I notice that there is a draft revision of EN 62304:2019 available (for purchase :confused:).

Given the concerns expressed in the paper posted, I presume that the new revision is a ways from being finalized?

That being said, I am interested in getting a jump on the major changes. Can anyone kindly link-to/summarize what notable changes to expect in the 2019 edition?

Thanks.
MM
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
I notice that there is a draft revision of EN 62304:2019 available (for purchase :confused:).

Given the concerns expressed in the paper posted, I presume that the new revision is a ways from being finalized?

That being said, I am interested in getting a jump on the major changes. Can anyone kindly link-to/summarize what notable changes to expect in the 2019 edition?

Thanks.
MM
Apparently you can browse the draft on EVS for 24h at a cost of 2 Euro.
 
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