Written by Expert Tutor and Industry Expert John Lafftery in response to his post on “What is the Difference between the EN and ISO versions of 14971:2019 Part 2?” The following query came from a reader; “Where does it say in the MDR that benefit-risk analysis is required for individual risks?” Read time: 3 minutes
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:
1. EU MDR 2017/745 Annex 1 General Safety and Performance Requirement (GSPR) No. 1 states ‘…. provided that any risks which may be associated with their use [the use of Medical Devices] constitute acceptable risks when weighed against the benefits’. The inclusion of the word ‘any’ indicates that each risk must be outweighed by the benefits otherwise the word ‘any’ would have been omitted.
2. EU MDR 2017/745 Annex 1 GSPR No. 4. states ‘To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable’. We know from GSPR No. 1 that risks can only be considered ‘acceptable risks when weighed against the benefits’; therefore, it follows from GSPR No. 4 that each risk must be weighed against the benefits’
3. EU MDR 2017/745 Annex 1 GSPR No. 2 states ‘The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio’. This statement has the implication that each individual risk must be outweighed by the benefits directly related to that risk. If the risk is not outweighed by the benefits directly related to that risk, then the risk should be eliminated where possible (or reduced as far as possible) even if this means foregoing the associated benefits, as to do so will improve the benefit-risk ratio. For example; if we have a device with a feature, the benefit of which is a reduction of one day in the average stay in hospital; however, the risk associated with that feature involves a high probability of death or serious injury to the patient, then clearly that risk cannot be justified by reference to the overall benefits of the device. Elimination of that feature and thus the elimination of the risk of death or serious injury would result in an average of one extra day spent in hospital whilst the patient would still receive all the other benefits arising from the use of the device.
4. In many cases, of course, specific risks cannot be directly related to individual benefits, there may be a one-to-many, one-to-all, many-to-many or many to all relationship or vice-versa. In these cases, individual risks or benefits may be grouped as appropriate.
5. The EU Medical Devices Directive 93/42/EEC (and updates) already requires that individual risks be outweighed by the benefits and that individual risks be included in Benefit-Risk analysis. This fact was clearly stated in Annex ZA of EN ISO 14971:2012 Content Deviation No.4: Discretion as to whether a risk-benefit analysis needs to take place. Paragraph C of Content Deviation No. 4 sates ‘Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.’
6. In addition, EU MDR 2017/745 Annex 1 GSPR No. 1 states that devices must be ‘compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art’. If an individual risk is not outweighed by the benefits directly related to that risk, then it is difficult to argue that risk is compatible with a high level of protection. 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)
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.
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