ISO 14971 and ISO TR 24971 revision

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Marcelo

Inactive Registered Visitor
#3
ISO TC 210 JWG 1 met this week in Israel to work in the revision of ISO 14971 and TR 24971. The meeting was very productive; the group was separated in task teams to deal with different aspects of the revision (for example, task team A +B is responsible for revising the topics Policy and criteria for risk acceptability, medical benefits, use of risk matrix and Risk-benefit analysis, medical benefits, effectiveness, patient perspective, preference data), and will work online during the next months to prepare the propose texts, for the next meeting in the Netherlands.
 

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Marcelo

Inactive Registered Visitor
#4
ISO TC 210 JWG 1 met this week in Delft, the Netherlands, to continue the work on the revision of ISO 14971 and ISO TR 24971.

The meeting was extremely productive - all the work of the task groups revising parts of the standard was revised, and a second pass of changes was made and an initial consensus was obtained in all the topics. Now, the Working Draft (internal do the JWG) will be revised and circulated for one more round of comments.

The next step is to finish the CD (Committee Draft( in the October 2017 meeting in Hiroshima, Japan, after which the CD will be distributed to National Committees for comment.
 

Marcelo

Inactive Registered Visitor
#6
ISO TC 210 JWG 1 met two week ago in Hiroshima, Japan, to continue the work on the revision of ISO 14971 and ISO TR 24971.

The focus of the meeting was the discussion of the internal comments to the WD of ISO TR 24971. We also discussed ISO/IEC Guide 63 (which was going to be circulated as a Guide but the circulation was postponed to after the comments to the ISO 14971 CD) and some of the text of ISO 14971.

There's still some homework to do in the following weeks, but the CD of ISO 14971 will be circulated to National Committees for comments before the end of the year.
 

locutus

Involved In Discussions
#7
Thanks for the update Marcelo. Can you also tell the Europeans to not be coy and release an EN version that just says follow ISO version? Bloody difficult to try an explain those deviations to normal people when appears was written by lawyers. I think group do their best doing risk management, so should not make it more complicated or over-burdensome. If they balk, just tell them the MDR already has all those deviations in the GSPR. Thanks ! :)
 

Marcelo

Inactive Registered Visitor
#8
ISO TC 210 JWG 1 met last week in London to resume the work on the of ISO 14971 and ISO TR 24971. We had a great meeting with great progress on the work. IN particular, we finished revising the almost 80 pages of comments for the CD of ISO 14971 and begun revision og the 110 pages of comments for ISO TR 24971. The expectation is that the revision will be finished in the next meeting, in June, in Long Beach, USA.
 

Marcelo

Inactive Registered Visitor
#9
The DIS (Draft International Standard) of the review of ISO 14971 - Health Product Risk Management - should be circulated to national committees soon. The ballot will remain open until mid-October.

It is extremely important for those involved to review and comment on the text, as this is the last chance for technical modifications to the project - if draft is accepted, technical requirements can no longer be modified until publication.

For each country, the availability of the document (which is copyrighted and not for open circulation) and means to comment depends on how the country deals with mirror groups to ISO TC 210 or ISO TC 210 JWG 1. Usually, there's a national mirror group that deals with the international work. Please inquiry at your National Committee organization.

In Brazil, the document is handled by WG 2 - Risk Management - from EC 26: 150.01 of ABNT CB 26. WG 2 members will receive and review the document.

The WG will also hold an open meeting for those interested to take note of the text and assist in creating the Brazilian comments. This meeting will be scheduled shortly.
 
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