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Interpretation and Application of Annexes Z in EN ISO 14971: 2012
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However, the EN at this time, does not include the Annex Zs. The National Foreword does state that the standard "does not contain Annex Z's" and will be updated with an amendment once finalized. Are we just in limbo until amendments are approved? Why the intermediary release? Super Moderator. Feb 24, BSI just published a paper on this. Sounds like limbo, indeed.Insight and Inspiration for Pharma Professionals.
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 s when the Directives were first being developed, and the AIMD Directive was published. The first standard in this space was ENwhich was developed to deal with risk analysis and became a harmonised standard in, I believe,so a few years after the Directive.
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.
Pharma IQ: That's a good background for the controversy. How have the expectations for risk management changed? C Sidebottom: T hose at the Commission that are responsible for medical device regulation began to serve us some questions back as early as with regard to how well they thought some of the standards were addressing the presumption of conformity with the essential requirements.
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 insubsequent 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. 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 mids.
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?Jupyterhub change password
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 ISOthe 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. 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 European adoption.
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Posted by Joe Hage. Meet your next client here. Join our medical devices group community. Private answer. This is an indication of how the standard meets the relevant essential requirements of the Medical Device Directive.
Since the requirement in the EU is to comply with the national transpositions of the Medical Device Directive, you should already be meeting those requirements. Your comments also reflect mine. I once had a Notified Body's Auditor asking my client similar question and he would take any explanation. I am inclined to believe that many Notify Body Auditors require standardized training. Patrick Druggan The Z annexes of the harmonised standards define what elements of the essential requirements that you do comply with.
My experience is that most people are unaware that these Annexes have specific direction to the elements you comply with in the MDD. You need to take the Z annexes and their statements about what you comply with and correct your essential requirements. That is my interpretation. Hi Robert, start by creating a checklist against the essential requirements of the directive and this should help to identify any shortfall. Reduce risk as low as possible ALAP I.
Patrick Druggan The ZA annex covers elements 1 to 6 and 7. It may be that you are still using the concept of ALARP and that is what you need to change in your procedures. Joy Frestedt summed up the update very well with one minor Correction.To view the pretty article, go here.
The normative content is still in accordance with ISO Manufacturers can use harmonised standards to meet the ERs or other provisions of the Directives. However, the use of these standards remains voluntary.How to make a lobby bot gift you
While very uncommon, Manufacturers are free to choose other technical solutions to demonstrate compliance with the mandatory legal requirements. The entry in the Official Journal reads as follows:. You must log in to post a comment. Skip to content Twitter LinkedIn. Manufacturers should take the following steps immediately: Update risk management procedures as needed to address the deviations described in the applicable Z Annex.
Update existing Risk Management Reports to comply with the deviations. Consider if design changes are needed to comply with the deviations. For example, since labeling can no longer be claimed to reduce risk, design provisions may be required to reduce the risk to acceptable levels.
Update references to EN ISO that may appear in quality system documents including technical files. The Directives require all risks to be reduced as far as possible and to be subject to risk-benefit analysis.
Does RM process allow some risks to be considered negligible and therefore not reduced by risk control measures? No risk reduction required for BACC risks. The Directives require all risks to be reduced as far as possible AFAP without economic considerations.
Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File
Does RM process allow risk controls to be limited for economic reasons? The Directives always require risk-benefit analysis, regardless of risk levels. The analysis must consider all individual risks and their impact on overall residual risk acceptability, weighing all risks combined against patient benefit. Does RM process require an overall risk-benefit analysis for the device?
The Directives require risks to be reduced until further control measures do not result in risk reduction. Does RM process require consideration of all possible risk control options, without stopping as soon as risks are reduced to an acceptable level? Does RM process require risk elimination or reduction as far as possible through inherently safe design and construction, and the application of safety principles and state of the art?
Labeling Information Cannot Influence Residual Risk : ISO describes three risk control options: 1 inherent safety by design, 2 protective measures, and 3 information for safety. The Directives view the third option as providing information on residual risk rather than reducing risk. Does RM process allow risks to be reduced through the provision of information for safety? The cost of implementing risk control measures is a factor in determining how to reduce risks.
Design measures and labeling warnings are implemented without considering protective measures in the device or the manufacturing process. Taking credit for warnings in the device Instructions For Use as risk reduction measures without verifying their effectiveness.Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products.
However, EU device manufacturers often struggle to effectively implement this particular requirement given how the standard was harmonized by the European competent authorities. Rather, the European Commission identified seven 7 so-called content deviations between the ISO and the regulatory requirements of the three 3 medical device directives for Europe.
These inconsistencies have caused confusion surrounding what processes to utilize when addressing risk. To assist EU device manufacturers in their understanding of how to effectively undertake risk management activities, provided below is information on the most significant changes pertaining to ISO The changes with the most significant impact are discussed throughout the remainder of this blog. The second deviation to ISO is specific to the risk evaluation process.
The ISO Standard version indicates in Annex D4 that the acceptability of risk is not specified by the Standard and must be determined by the manufacturer.
In Clause 3. This particular risk management policy is intended to indicate a threshold for risk acceptability.
In Clause 5 of the Standard, the manufacturer is instructed to evaluate whether risks are acceptable using the risk management criteria defined in the risk management policy. It is quite common for medical device makers to establish a policy that all risks must be below a quantitative threshold; e.
For EU manufacturers of novel devices, it is strongly recommended that all foreseeable risks are benchmarked against known risks of existing similar devices.Make samba faster
If the novel device presents equal or lower risks than existing devices, the risks of the novel device can be considered acceptable.
In order to comply with the risk management portion of EN ISOrisk controls must be implemented for all risksregardless of acceptability. The acceptability of risk cannot be based solely on technological design features and physical performance test results.
Since Junethe Clinical Evaluation Report CER must be based on clinical evidence of the device under evaluation for its intended medical purpose, including known and foreseeable side effects and potential complications.
However, in the informal section of ISO D. Clauses 6. Both Essential Requirements, 6 and 6a, directly connect the acceptability of risk when evaluated against probable patient benefits with the requirement of a clinical evaluation assessment as set forth in Annex X. While this guidance document states in Section 2. Only the text of the Directives is authentic in law.
In current regulatory compliance practice, EU Notified Bodies only accept clinical evaluation assessments following the above referenced non legally binding MEDDEV guideline on a clinical evaluation process with the following outcome:.
The harmonized EN risk management version includes the mandatory collection and evaluation of post-production market information. In case post-production information reveals previously unrecognized hazards, hazardous situations, or different risk estimates e.
It is essential that medical device manufacturers accurately understand the significant content deviations between the EN ISO Risk Management Standard and the current Essential Requirements of the EU device directives in order to effectively address and change associated risk management and clinical evaluation processes:. In fact, our internal teams of medical device development experts communicate with EU entities nearly every day.
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Need to register?Toggle navigation. ISO has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the revision which otherwise may go unnoticed but which have significant impact to the risk management file.
Instructor: David Amor. Email this page. Download Agenda. Book this course. Get life time access for unlimited participants. Popular Courses by David Amor. Become a Speaker.
How it works. Instructor Profile: David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. David has a strong technical background, having garnered his BS and MS in Biomedical Engineering from the University of Miami with a focus on innovating around clinical needs.
He also currently serves as Chief Operating Officer of ReMind Technologies, a mobile health start-up dedicated to tackling medication adherence by using smart-device based medication dispensing units and software applications. View More. Download Name is Required. Your webinar shared successfully!
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