What Does Annex Z of EN/ISO 14971: 2012 Mean & How Can We Practically Implement It?

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Helen Winsor

Chuck Sidebottom , Director, Corporate Standards at Medtronic and Dave Osborn, Manager, International Standards at Philips, join Pharma IQ to discuss the current controversy over the application of risk management under the European medical device Directives, how the expectations for risk management have changed, how EN/ISO 14971 has been revised to deal with these expectations and how manufacturers and notified bodies are reacting to these revisions, which are causing a degree of confusion.

Pharma IQ: What is the background on the current controversy over the application of risk management under the European medical device directives?

C Sidebottom: I might start by saying that, of course, the history of risk management and the directives goes back to the early 1990s when the Directives were first being developed, and the AIMD Directive was published. The first standard in this space was EN 14491, which was developed to deal with risk analysis and became a harmonised standard in, I believe, 1997, so a few years after the Directive. About the time that standard was published and harmonised it became clear that more than risk analysis needed to be covered, and work was already underway in the ISO community to develop a risk management standard that resulted in ISO 14971, which first edition was published in 2000, and then harmonised as EN/ISO 14971 shortly thereafter. I think there's some important information in the harmonisation statement for that standard which I'd like Dave to comment about.

D Osborn: We're talking about the terms of recognition, which is the European Union's means of telling you how the standard relates to the essential requirements and how it gives you a presumption of conformity, which is what a harmonised standard does. In the Annex Z – which is the Annex at the back of European Norms that tells you how the standard relates to the legal, essential requirements of the appropriate Directives – it states that compliance with all the required clauses in this standard will ensure that general aspects of medical devices related to patient risk and safety have been addressed, and then goes on to talk about how, for a particular device there may be additional considerations in particular device standards. But, that's a very strong statement that says that ISO 14971:2000 or EN/ISO 14971, in fact, fulfils the obligation of the Directive, and that was everyone's understanding in 2001 when this standard was harmonised.

Pharma IQ: That's a good background for the controversy. How have the expectations for risk management changed?

C Sidebottom: Those at the Commission that are responsible for medical device regulation began to serve us some questions back as early as 2009 with regard to how well they thought some of the standards were addressing the presumption of conformity with the essential requirements. That all came to a head in late-2010, when the Commission actually issued a formal objection to 11 standards, including EN/ISO 14971, and at the time was the 2009 version, now subsequently re-released as the 2012 version. I think it's important to mention at this point that we talk about the EN/ISO standard, but they all relate to the ISO version, the second edition, which was published in 2007. That ISO standard has not changed, even though there are more recent European adoptions. I think it's important to remember that.

D Osborn: When we say European adoptions, what we mean is they've changed this Annex Z telling you how the standard relates to the Directives. Perhaps it's also important to point out that there was a significant political change in Europe in 2009, subsequent to the European Parliament elections and at that time, medical devices as a sector were transferred from DG Enterprise, which in American terms is like the Department of Commerce, to DG SANCO, which is a part of the European Commission that's responsible for consumer affairs. I don't want to sound too pejorative, but the bureaucrats responsible for administering the Directive became different individuals with a different focus, and it was at that time this controversy began to occur.

Pharma IQ: How has EN/ISO 14971:2012 been revised to deal with these expectations?

C Sidebottom: Those in the Commission that are responsible became concerned that the process and the standard wasn't fully aligned with their interpretation of the requirements of the Directive. I think fundamentally what happened was the people at the Commission began to take a different look at the words and the Directive than had been applied since the medical device Directives and the other Directives came into play in the early to mid-1990s. There was, I think, a re-appraisal by folks in Brussels of what the words in the medical device Directives said with regard to how risk needed to be managed for these devices. Dave, what's your gut on that?

D Osborn: I think that was very well stated. My interpretation is that, in fact, the Commission's interpretation of the Directive has changed, which is to say we have now a different set of individuals responsible for administering the medical Directives, and they have read the text and concluded that the meaning is different than had been the universally or nearly-universally accepted understanding of what the meaning had been for the preceding decade.

Pharma IQ: How are manufacturers and notified bodies reacting to these revisions?

C Sidebottom: I think before we move to that point, we probably should say a couple of things about how these new so-called Z Annexes are structured. They list among them a number of what are called content deviations.

Pharma IQ: Can you define exactly what this means?

C Sidebottom: That's one of the things that, of course, we as manufacturers and the industry in general and the notified bodies that the certifying organisations are all struggling with, is to figure that out. From the standards point of view, I think certainly the international committee that's responsible for ISO 14971:2007, the root standard, consider that the standard is the generally acknowledged state of the art from a management system standpoint and, consequently, have reconfirmed the standard and decided that today there are no changes that are appropriate to the ISO standard. That's why it's been reconfirmed. I think there are a couple of issues with the interpretation of the Directive that are expressed in this content deviation where there is some conflict with the wording in the standard. But, in the main, the standard does not define the endpoints of risk management, in that that's the responsibility of the manufacturer, and they have to do it within the context of the legal regulatory environment in the places where they want to sell the device. I think the view of the international community is that the standard itself is quite happy with the endpoints that the European Commission has interpreted the Directive with a couple of exceptions. We'll certainly be talking about those exceptions at the conference in January.
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Pharma IQ: How are manufacturers and notified bodies reacting to these revisions? Is there just confusion?

D Osborn: The short answer is with great confusion.

C Sidebottom: Yes, I was going to say that I think the moral is still very much up in the air with the manufacturers and with the notified bodies – how to practically deal with these "content deviations" that are listed in the Annex to the 2012 European adoption. I think that's going to continue to evolve. At one end, you could basically say the result of this interpretation is that almost no medical device currently on the market in Europe satisfies the requirements.

D Osborn: Of the Directive as it's being interpreted.

C Sidebottom: Yes, and yet millions of devices are being used every day, safely and to treat patients and to provide a great bit of benefit. The answer has got to fall somewhere in between those two extremes. I think we're all – manufacturers and notified bodies alike – struggling to really figure out what do the current interpretation of the Directives mean, and how can they practically be implemented?

D Osborn: I think that last point is the most problematic one. How can one practically or practicably do what is now written in that Annex Z? Until there is agreed-to guidance, everyone is struggling equally, trying to figure it out. It will be a very interesting time that we live in until there is additional clarity.

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