ISO_14971_revision_process

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not only Technical Committee 210, responsible for medical device quality standards, but also to IEC SC 62A which is responsible for medical device electrical safety standards.

JWG1, as the technical committee is known, is responsible for medical device risk management and is the author of the ISO 14971 medical device risk management standard, and its accompanying guidance document, ISO TR 24971, an ISO Technical Report.

In 2016, the ISO Technical Management Board assigned JWG1 the task to revise the two documents, to address comments received during the recent voting process to reaffirm or revise the documents. The assignment from the ISO Technical Management Board included the statement that the risk management process was not to be revised. A requirement to move most of the informative annexes to the TR 24971 was also included, as the TR could be more easily revised as the need arises, thus negating the requirement to reopen the standard each time informative annexes need revision.

The process to revise and update began in Tampa, FL in 2016 and continued in 2017 meetings in Delft, Netherlands, and Hiroshima as well as a number of WebEx meetings of task teams assigned to specific areas. The process will continue until the revised documents are released, which is scheduled to be in the third quarter of 2019.

A meeting of JWG1 was held in London, at the headquarters of BSI, in conjunction with the meeting of IEC SC 62 during the week of April 9, 2018. Thirty-six representatives from sixteen countries from all regions of the world participated in this meeting. Additional meetings of JWG1 are scheduled for Long Beach in June, in conjunction with AAMI’s annual meeting and in Seoul, Korea in November in conjunction with the ISO TC 210 meeting, followed by a meeting in early 2019 in São Paulo, Brazil. In addition to these face-to-face meetings, additional WebEx meetings of various task teams with assignments to prepare proposals on addressing comments submitted by national committees during the voting process will also proceed.

What is important to the industry is the direction this process is taking, which is to NOT revise the risk management process, which was a direction of ISO, but rather to improve the information on implementation of the process of risk management. So, companies with processes that currently conform to the standard should not have to revise their processes to comply with the new document, as it is presently being envisioned. One technicality that will be seen is the addition of a new Clause 2 as required by ISO to identify Normative References, even though there are none. That will change the numbers of all following Clauses which will index by one, thus the Definitions, presently in Clause 2, will now be identified as Clause 3, etc.

Another item being tackled by the joint working group, however, is the growth of risk-benefit (or benefit-risk) being discussed by the regulators. Since the term “benefit” is not defined, it will be defined in the upcoming revision. The term “risk” is already defined in the standard. Since its first release the standard has discussed risk-benefit analysis, so the defining of benefit is overdue. The current requirements for risk-benefit analysis are not expected to change, at this point.

Another important factor is that ISO 14971 is an international standard and recognized throughout the world. Some regions (such as EU), and countries may add to the informative annexes, but they cannot revise the standard’s requirements. The EN ISO 14971:2012 confused that position when CEN published their version of the risk management document. The CEN document contained informative annexes, not requirements, that identified what the committee felt were shortcomings in the risk management process that failed to meet requirements of the Medical Device, Active Implantable and In Vitro Diagnostic Directives in the EU. There was a great deal of controversy over what many felt were misinterpretations of the standard, but this only applied in the EU. The recently published Medical Device Regulation in the EU addressed the controversial points, albeit indirectly. The new edition of ISO 14971 will continue to be an international standard and will not address national and regional issues; these will be left up to the national and regional standards bodies. While EN ISO 14971:2012 is harmonized to the Medical Device Directives, it is not harmonized to the Medical Device Regulation. A new CEN document will have to be created to address these differences, and that may not happen until the new ISO 14971:20XX is released. While a number of European countries are represented in JWG1, there is no official CEN participation in the development of the new edition. A harmonization process for the new regulation in Europe has not been established, and furthermore, hundreds of standards had not been harmonized to the Directives as late as November 2017. So, it appears as though Europe will be one uncertainty with which industry will be dealing for a while.

ISO TR 24971 will be the repository for most of the informative annexes formerly in ISO 14971, again for ease in revision and updating according to ISO processes. What is expected to remain in ISO 14971 is the annex that provides the rationale for the requirements in the standard, presently Annex A, which every user of the standard should review; the flowchart in the present Annex B; and the present Annex E with concepts highlighted. Current Annex E will become a revised Annex C in the new document if all proceeds according to the present plan. The rest of the Annexes in 14971 are presently slated to move to ISO TR 24971. The work of JWG1 will be moving to revision of 24971 over the next few months as this document has swelled to over 100 pages in its present form, without Annexes A-C in the new 14971, which is not likely to persist. All the informative annexes in the current 14971 and 24971 currently number around 75 pages. A new draft of ISO TR 24971 for circulation and vote will not likely appear in 2018.

Industry may expect to see a Draft International Standard 14971 (DIS) to be published later this year for vote. National Committees will circulate this document for review and comment, and then will vote on its acceptance as a DIS. The comments received will be incorporated by JWG1 in a Final Draft International Standard or FDIS which will be circulated for a final vote for acceptance. One should note that ISO 14971 is the only standard known to have been accepted with a 100% affirmative vote for both the 2000 and the 2007 editions by both ISO and IEC member committees. Hopefully, JWG1 can repeat this accomplishment.


Read the Definitive Guide to ISO 14971