Author: Nupur Srivastava, PhD
The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is not only safe but also provides a medical benefit. The reference to benefit is included throughout the standard, and the definition for “benefit” is included for the first time.
ISO 14971:2019 Definition of Benefit: a positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.
As outlined in the standard, risk has two key components:
The newest ISO 14971:2019 standards emphasize that manufacturers need to demonstrate that the benefits outweigh the risks, as well as mitigating risks. Clause 7.4 of ISO 14971:2019 has even been retitled “Risk/Benefit Analysis” to align with regulatory changes.
Examples “benefits” provided ISO 14971:2019:
The guidance document ISO/TR 24971:2020 also provides clarification and examples of risk-benefit decisions. The TR 24971 provides three-page guidance on figuring out benefits and includes examples. The draft standard comprehends that manufacturers can change a product only if residual risks offset the benefits.
Industry expert and convener of ISO Technical Committee 210 and Joint Working Group 1 (TC210/JWG1), Jos Van Vroonhoven, and a member of ISO TC210/JWG1 and long-time industry expert, Don Powers, provided some insight on what this means for industry in an interview with Medtech Insight. The objective when developing the revision was to keep the reference standard document the same (as much as was possible) while aligning with global regulatory requirements and providing more clarification on how manufacturers can achieve regulatory compliance and provide benefit to patients.
They stressed that manufacturers need to consider that this further guidance on risk-benefit analysis is designed to help in the estimation of anticipated benefits that is based on positive impact on clinical outcomes and related factors. Many factors can influence the risk-benefit balance, such as changes to medical practice, clinical data that confirms additional benefits to patients, change in the patient population that uses the device, and the introduction of other devices on the market.
It is also recommended that manufacturers take a close look at Clause 10 of TR 24971:2020, which is full of helpful post-production information.
In addition to defining benefits, ISO defined residual risk as the “risk remaining after risk control measures have been implemented.”
ISO TR 24971:2020 provides further guidance on benefit-risk analysis, firstly by helping in estimation of anticipated benefits, based on positive impact on clinical outcomes and related factors, and then providing criteria for comparing benefit and risk to find if the overall residual risk is outweighed by the benefits.
“In general, the benefit-risk analysis should not only include theoretical risks and benefits, but rather be supported by objective evidence. The benefit-risk evaluation can be done on individual residual risk or on the overall residual risk,” said Van Vroonhoven.
In summarizing the benefit to risk analysis, Don Powers said companies should look at their overall residual risk, which they will always need to do in comparison to the benefits, regulatory requirements, and all applicable processes based on the guidelines of ISO 14971:2019 and TR 24971:2020.
Regulatory authorities are now demanding that the balance for medical devices must favor the benefits and device manufacturers must conform to ISO 14971:2019 over the next few years if they have not done so already.
Criterion Edge has a team of expert medical writers available to help your organization with Risk to Benefit Analysis in the Risk Management Reports and integration throughout the MDR and IVDR documents as you get ready to meet these new global regulatory challenges. Please reach out to us for a free consult.
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Watch this video to learn how Criterion Edge is different from the rest.
This infographic goes through 5 key questions to go through in order to control your budget.
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
This piece discusses 10 key strategies to building an efficient regulatory writing process.
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Read more about our privacy policy here.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages.
Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!
