In this regulation more emphasis is place on closing the loop between original risk identification, analysis and evaluation during the device development and investigation phases and the data collected for Post-Market Clinical Follow-up.
Also, a numerical benefit-risk determination is proposed.
The following definitions are included in this discussion:
- (53) clinical benefit
- (23) risk
- (24) benefit-risk determination
Risk
(23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
Benefit-Risk Determination
(24) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
Clinical Benefit
(53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.
Risk Management will be covered in more detail in EU MDR 2017/745 – Module 2 – Chapter II, Articles 5-24 – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement and ANNEX I – General safety and performance requirements.