XP S99-223 : Medical Device – Benefit / Risk management : preview
You will find below an overview of the XP S99-223 French experimental standard, relating to the management of the benefit / risk ratio of medical devices, available in January 2020 on the Afnor edition website.
caution: this is an unofficial (and automatic) translation
Voir la version française
Rating index: S99-223
T1 Medical devices
T2 Benefit/risk management
This document has been prepared by the afnor committee S95B, Quality management and related general aspects of medical devices.
Attention is drawn to the fact that some of the elements of this document may be subject to intellectual property or similar rights.
For the relationship with European Regulation (eu) 2017/745, see Informative Annex Z.
1 Scope 7
2 Normative references 7
3 Terms and definitions 7
4 General requirements 10
- 4.1 Benefit/risk management process10
- 4.2 Risk-based approach 11
- 4.3 Consideration of other activities of the organization 11
- 4.4 Management responsibility. 13
- 4.5 Management of persons involved in benefit/risk management 14
- 4.6 Key data management 14
- 4.7 Record management 15
- 4.8 Benefit/risk management plan 15
- 4.9 Reviews 16
- 4.10 Updates 16
- 4.11 Removal of the device 17
5 Consideration of opinions 17
- 5.1 General 17
- 5.2 Consideration of patient opinion 17
- 5.3 Consideration of other opinions 18
6 Benefit analysis 18
- 6.1 Identification of benefits 18
- 6.2 Estimate of benefits 18
- 6.3 Key data for benefit/risk assessment 18
7 Risk analysis 19
- 7.1 General 19
- 7.2 Risk control and risk acceptability requirements 19
- 7.3 Key data for benefit/risk assessment 19
8 Estimate of benefit/risk ratio 19
- 8.1 Benefit/risk ratio of the different intended uses 19
- 8.2 Identification of the different possible situations 19
- 8.3 Identification of uncertainties 20
- 8.4 Estimate of the temporal evolution of the benefit/risk ratio 20
9 Assessment of the acceptability of the benefit/risk ratio 20
- 9.1 General 20
- 9.2 Evaluation planning. 20
- 9.3 Input data for the evaluation. 21
- 9.4 Evaluations 21
- 9.5 Conclusions 21
- 9.6 Special cases 22
10 Information provided with the device 23
- 10.1 General 23
- 10.2 Information to shape patient opinion 24
- 10.3 Information provided to professional health users 24
- 10.4 Information provided in the context of clinical investigations 24
11 Post-market surveillance. 24
- 11.1 General 24
- 11.2 Monitoring of the device and its use. 25
- 11.3 Monitoring the evolution of the context 25
- 11.4 Monitoring the number of devices on the market and their use. 25
- 11.5 Definition of thresholds and indicators for monitoring 25
- 11.6 Consideration of post-market data. 26
- 11.7 Vigilance 26
12 Regulatory communications 26
Appendix A (informative) Risk-based approach 28
Appendix B (informative) Principles of risk-benefit ratio management 31
- B.1 Notations 31
- B.2 Concepts around the use of a device 31
- B.3 Key data 33
- B.4 Identification of risks and benefits 33
- B.5 Estimation of risks and benefits 34
- B.6 Risk management 35
- B.7 Estimate of benefit/risk ratio 37
- B.8 Acceptability of the benefit/risk ratio 37
Appendix C (informative) Benefit/risk management file 39
- C.1 Benefit/risk management plan 39
- C.2 Definition of the context for the analysis of the benefit/risk ratio 39
- C.3 Analyses relating to benefit/risk management 40
- C.4 Assessment of the acceptability of the benefit/risk ratio 40
- C.5 Post-market surveillance. 40
- C.6 Modifications 41
- C.7 Vigilance 41
Appendix D (informative) Identification of opinions 42
- D.1 Objectives 42
- D.2 Identification of useful opinions 42
- D.3 Cases likely to produce an adverse opinion 42
- D.4 Methods of identifying opinion. 43
Appendix E (informative) Risk, benefit and benefit/risk estimates and post-market measurement 44
- E.1 Probability 44
- E.2 Severity 48
- E.3 Importance 51
- E.4 Risk 53
- E.5 Profit 54
- E.6 Overall risk and overall benefit 55
- E.7 Benefit/risk ratio 56
- E.8 Possible situations 57
- E.9 Benefit/risk ratio for a patient population 59
- E.10 Post-market surveillance. 59
Appendix F (informative) Data visualization 62
- F.1 Scales 63
- F.2 Table 63
- F.3 Tree 64
- F.4 Forest 65
- F.5 Stacked histograms 65
- F.6 Infographic 66
- F.7 Other representation formats 67
- F.8 Choice of units 67
Appendix G (informative) Assessment of the acceptability of the benefit/risk ratio 68
- G.1 Forms of evaluation 68
- G.2 Sensitive points 68
- G.3 Missing data 69
Appendix Z (informative) Consideration of Regulation (eu) 2017/745. 70
The requirements of this standard provide a framework for assessing the acceptability of the risk-benefit balance of medical devices. This standard has been developed specifically for manufacturers of medical devices.
Risk-benefit management consists of identifying, selecting, analysing, summarising, interpreting and monitoring key data, as well as informing and taking into account the views of interested parties.
NOTE : Stakeholders include the manufacturer, patients, patient associations, patient relatives, health professionals, notified bodies and competent authorities.
Risk-benefit management is necessary to establish and maintain regulatory compliance of a medical device. Benefit/risk management takes into account benefits, risks, intended use, patients and the medical and technical context. Managing the risk/benefit balance requires active communication between stakeholders.
The requirements of this Standard have been designed to optimize documentary effort, using processes already in place within the organization. This Standard provides a formal, transparent and objective approach to providing common principles and vocabulary for different stakeholders.
A framework for the analysis of the benefit/risk ratio is defined in the requirements of the standard, methods are presented in the annexes for information purposes.
The benefit/risk ratio is assessed at the patient level, taking into account their opinions.
The requirements for managing the risk/benefit balance are applicable using a risk-based approach.
In this Standard, the following verbal forms are used:
- ” must” indicates a requirement ;
- “should” indicates a recommendation ;
- ” can” indicates a permission, possibility or ability.
Information in the form of a “NOTE” is provided to clarify the associated requirement or to facilitate its understanding.
NOTE : When used alone, the term “analyses” includes risk, benefit and benefit/risk analyses.
Scope of application
This Standard specifies the terminology, principles and a process for managing the risk-benefit balance of medical devices.
This Standard does not specify an acceptable benefit/risk ratio, but requires the organization to define methods for assessing the acceptability of the benefit/risk ratio for each intended use.
This Standard is based on the organization’s risk management, usability engineering, pre-clinical assessment, clinical evaluation, post-market surveillance and quality management system, implemented in accordance with applicable regulatory requirements.
This Standard is intended for medical device manufacturers and other stakeholders, including competent authorities and notified bodies.
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14971, Medical devices – Application of risk management to medical devices.
ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971.
IEC 62366-1, Medical devices – Application of usability engineering to medical devices.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice