Richard,
the Proposed Z Annexes are part of the published FDIS that you can read in the purchased document. The Z Annexes have been submitted to CEN for a final vote as a EN standard (the complete standard and Annexes). A Harmonization consultant reviewed and commented on the Z annexes and they were revised based on the comments. It was important to provide the 3 Directive Annexes since the Directives would still be in effect at the time of release, and due to the errors in the 2012 EN standard that needed correction.
An acceptance by CEN with a positive vote is merely the first step as the standard must go thru the Harmonization process. And for the MDR/IVDR there presently is no process. So like other parts of the Regulation process, it may not be ready for some time, leaving manufacturers in a real difficult situation. You can go with the standard as written, expecting that it will be Harmonized, or develop processes that you believe meet the Regulations and hope that there is a Notified Body for your products in place in time.
As the EC insists that manufacturers meet the requirements next May and that THEY will have their part of the process in place by the day manufacturers must've meet the requirements assured problems. Unfortunately the lack of Notified Bodies and other parts of the process practically guarantees that many devices will not be ready in time to sell in Europe.
At this time, what is available in the FDIS may be the best alternative with an 80-99 percent probability of being in agreement with the EC. Still uncertainty!
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 27-May-2019 07:08
From: Richard Vincins
Subject: ISO FDIS 14971:2019
Thanks Ed for this information !
Do we anticipate the EN ISO 14971 version with the 'Z' annexes will still have those deviations or will the ISO 14971:(2019) version close some of those? I can imagine maybe the 'Z' annexes for AIMDD/MDD/IVDD will still be there though really a moot point at this time since they will be gone in just about 364 days. What I am more interested in the fact the General Safety and Performance Requirements (GSPR) have really integrated many of those deviations that were in the EN ISO 14971:2012 version. Did they at least get some of those in the new version so everyone is on the same page?!?
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 25-May-2019 08:31
From: Edwin Bills
Subject: ISO FDIS 14971:2019
AAMI has offered for sale the Final Draft International Standard, ISO FDIS 14971:2019. This document will be extremely close to the standard when it released late this year as only editorial changes are allowed at this stage. The document also includes five proposed Z Annexes for the CEN version of the standard. The five include annexes for the MDD, AIMDD, IVDR, MDR, and IVDR. The annexes still must go thru the Harmonization process to be accepted after CEN publishes their version of the standard. Currently their is no Harmonization process for the MDR or IVDR, and the process for the other three Annexes has a huge backlog.
See www.aami.org/store for more information.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
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