Written by John Lafferty Show
Read time: 3 minutes In response to my post on What is the Difference between the EN and ISO versions of 14971:2019 Part 2? I received the following query from a reader; "Where does it say in the MDR that benefit-risk analysis is required for individual risks?" MDR must be interpreted as requiring benefit-risk analysis for Individual Risks:This post sets out the rationale as to why the MDR must be interpreted as requiring benefit-risk analysis for Individual Risks (in addition to the requirement for an overall benefit-risk analysis). Indeed benefit-risk analysis of individual risks was already a requirement for Medical Devices sold in the European Union under the Medical Devices Regulation as shown below. 6 Reasons why Individual Risks require Benefit-Risk Analysis under the EU MDR:
I have referenced the EU MDR 2017/745 above throughout; it is important to note that the above applies equally to the EU IVDR 2017/746. CEN's Opinion on Benefit-Risk Analysis for Individual Risks Should be Revealed Shortly:Finally, it will be interesting to see the opinion of CEN on this question which we should learn shortly when EN ISO 14971:2019 is republished in the coming month(s) with Z Annexes (outlining the relationship between the ISO 14971:2019 and the MDR) Share your thoughts on Benefit-Risk Analysis for Individual Risks under MDR:Like all documents, the Medical Devices Regulation is open to interpretation. If you are a Medical Device manufacturer, what is your view and what approach does your company intend to take on this question? Also, if any readers are members of a Notified Body, we would welcome your views on this subject because, as we know, it will be the Notified Bodies who will be asked to adjudicate on the acceptability of Benefit-Risk analysis documents. You can follow the Northridge Quality and Validation LinkedIn Company page for more updates. ISO 14971:2019 Training Course InformationI run a comprehensive training course on ISO 14971:2019 via our training partners, SQT Training. This course is delivered via Zoom. Course Title: Quality Risk Management and ISO 14971:2019 Course Content: The course will cover the principles and practices of Risk Management and the actions that Medical Device Manufacturers need to do to comply with ISO 14971:2019 and the Medical Devices Regulations. Course Date and Booking: See details and book the course here. Ongoing updates on ISO 14971If you wish to get our updates emailed directly to your inbox, sign up for our eNewsletter here. About the Author - John LaffertyJohn Lafferty is the managing director of the Northridge Quality & Validation. Specialties: His specialties include Software Validation, MDSAP, ISO 13485, ISO 14971 and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education, Certificate in Quality Management. Experience: He has over 25 years’ experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe. SQT Training Tutor: John is also a Life Sciences Tutor with SQT Training Why is a risk analysis important?Risk Analysis is a proven way of identifying and assessing factors that could negatively affect the success of a business or project. It allows you to examine the risks that you or your organization face, and helps you decide whether or not to move forward with a decision.
Why is risk/benefit assessment important?Benefit-risk assessment is an integral part of FDA's regulatory review of marketing applications for new drugs and biologics. These assessments capture the Agency's evidence, uncertainties, and reasoning used to arrive at its final determination for specific regulatory decisions.
Why is it important to assess the risk and benefit of an intervention treatment prior to conducting research from an ethical perspective?assessment of risks and potential benefits is central to determining that a research study is ethically acceptable and would protect participants, which is not an easy task, because there are no clear criteria for IRBs to use in judging whether the risks of research are reasonable in relation to what might be gained by ...
Why cost benefit analysis is important for risk management?Cost-benefit analysis (CBA) is commonly applied as a tool for deciding on risk protection. With CBA, one can identify risk mitigation strategies that lead to an optimal tradeoff between the costs of the mitigation measures and the achieved risk reduction.
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