December 7, 2020

Risk Benefit Analysis and Residual Risk are Key Components of ISO 14971:2019

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 probability of occurrence of harm; and 
  • The consequences of that harm, that is, how severe it might be. 

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: 

  • Positive impact on clinical outcome 
  • Patient’s quality of life 
  • Outcomes related to diagnosis 
  • Positive impact from diagnostic devices on clinical outcomes 
  • Positive impact on public health 

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. 

Closeup of risk and benefit wooden blocks on seesaw against gray background

Risk-Benefit Analysis 

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.  

Residual Risk 

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.  

Deadlines to Meet? 

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. 

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December 1, 2020

[FEATURED] Making The Leap From EU MDD To MDR Clinical Evidence (Part 1): Practical Advice

Clinical evidence requirements are among the biggest challenges for manufacturers meeting the requirements of the EU’s new Medical Device Regulation. Maetrics’ Amie Smirthwaite explains how manufacturers should transition from the one to the other in part one of a three-part interview series with Medtech Insight.

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November 18, 2020

Medical Device Manufacturers Transitioning to ISO 14971:2019 Need to Perform a Gap Analysis and Create a Cross-Functional Risk Management Team

Author: Nupur Srivastava, PhD 

There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019,  and experts agree that medical device manufacturers need to perform a gap analysis and create a cross-functional team to meet these risk management requirements.  

Risk management plays a critical role in getting medical devices into the market, and ISO 14971:2019 “was designed to better align with medical device regulations around the world.” The global regulatory landscape has been very dynamic around the areas of risk management, as well as safety and performance. 

Tips on Putting Risk Management into Quality Systems During the Transition to ISO 14971:2019 

Two experts shared insights during an interview with Medtech Insight. Jos Van Vroonhoven, convener of ISO Technical Committee 210, Joint Working Group 1 (TC210/JWG1) and a senior manager for standardization for device giant Philips Healthcare, and Don Powers, a member of ISO TC210/JWG1 and long-time industry expert, said that the third edition of ISO 14971 provides more precise guidance and greater detail in the application of risk management concepts.  

These experts provided specific tips on how to transition ISO 14971:2019 into your device’s quality systems.  

Since ISO 14971:2019 instructs manufacturers how to best put together risk management programs, this is a good time to review risk management procedures and perform Gap Assessments. 

  • Develop a Gap Assessment Team 
    • Led by quality assurance or a designated risk manager 
    • Consisting of members with expertise in:
      • Clinical knowledge of the device 
      • Regulatory knowledge, global if needed 
      • Manufacturing of the device 
      • Design and development 
      • Marketing 
      • Reliability engineer and service organization, if available 
  • Divide the Gap Assessment Team and Conquer Each Area 
    • Compare required ISO 14971:2019 to current company processes 
    • Determine how this will impact each department 
  • Document Risk Management to Evaluate Residual Risk 
    • The panelist placed particular emphasis on residual risk, or the risk that remains after risk control measures have been implemented, which is new in ISO 14971:2019. Evaluating and Setting criteria for risk management can be found in Clause 4.4e Risk Management. 

How Do You Know If You are On the Right Track? 

Create another team to evaluate residual risks. This group needs to form a cross-functional team of experts with application and clinical knowledge that can provide good judgment for the residual risk of the medical device.  

The example provided explored the residual risk of x-ray equipment. In this case, the residual risk team might be comprised of individuals with expertise in the following areas. 

  • Radiation  
  • Technical director 
  • Chief medical officer  
  • Clinical scientist that understands how the equipment is used in hospitals. 

The standards outlined in ISO 14971:2019, like benefit-risk analysis, are now in demand by global regulators.  

Global Regulations 

The ISO 14971 standards were updated in 2019 in the United States and the European Union to conform to the higher expectation of identifying and mitigating risks associated with a medical device throughout its lifecycle.  

In the US, FDA requires device manufacturers to align with ISO 14971:2019 by the end of the transition period December 25, 2022, after which time FDA will no longer accept the previous ISO 14971:2007 version.  

In Europe, ISO 14971:2019 (EN version) aligns with the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) safety and performance requirements. Although it is not yet harmonized with these standards, ISO 14971:2019 is expected to become a Harmonized standard, which will make it state-of-the-art. The date of application for MDR (26 May 2021) and IVDR (26 May 2022) is quickly approaching.   

Globally, ISO 14971:2019 is considered the international standard for risk management and is referenced, if not endorsed, by all other major markets that require the application of risk management including, Australia TGA, Brazil, Health Canada, and Japan MHLW.  

Therefore, device manufacturers must begin to transition into compliance with the revised version of ISO 14971:2019 to align with global regulations. 

History of ISO 14971

The first edition of ISO 14971 was released in 2000 to assist manufacturers, regulatory bodies, and healthcare providers in managing the medical devices’ potential risks. This picture depicts the evolution of ISO 14971 from 2000 to 2019.  

Progression of ISO 14971  

As global regulations for medical devices are becoming more stringent, clear documentation of the process and presentation of the data are essential components of getting medical devices to market. Criterion Edge has a team of expert medical writers that can help your organization get the required documents completed in a timely manner.   
Please reach out to us for a free consult. 

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November 10, 2020

[FEATURED] How To Register In Eudamed By The December Start Date Commission Explains

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

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October 27, 2020

[FEATURED] Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued

The initial virtual audit ban is just one obstacle to timely EU MDR compliance. Another is that many companies have seriously underestimated how much time they need, even with the grace period.

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