As part of the technical documentaiton, risk analysis is an obligatory product launch requirement for every manufacturer. These requirements are specified in Medical Device Directive 93/42/EEC and, respectively, in the German Medical Devices Act (Medizinproduktgesetz – MPG). From 2020, the recently released Medical Device Regulation will become the mandatory source in all EU-member states.
According to Risk Management under EN 14971, the entire product life cycle has to be examined. It consists of all stages from development, through manufacturing, including post-distribution market monitoring, as well as, withdrawal. Risk Management implies the analysis and evaluation of the implemented measures to prevent new risks during usage.
The aim is to eliminate or, at least, minimize risks through conceptual or constructive measures. In case it is not possible, at least precautionary measures need to be taken. This option means informing users about residual risks (warnings). In doing so, the potential risks need to be reasonable for product usage (in comparison with the medical benefit) and consistent with health and safety measures.
- Workflow description
- Form sheets
- Risk management plan
- Proof of standards
- Product feature protocol
- Foreseeable safety hazards
- Analysis tables and acceptance matrix
- Management report and proof structure
- Action plan
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