Risk management: risk analysis, risk management plan and risk assessment according to MDR.

Medical devices must be safe

Efficient risk management is essential to ensure the safety of a medical device. As with drugs, medical devices must be safe!

The risks to patients and users that may arise from the use of medical devices must be kept as low as possible, and must be outweighed by the benefits of the medical device, resulting in a positive risk-benefit ratio. Risks must be minimized as far as possible, especially with regard to the risk-benefit ratio.

Your obligations as a manufacturer

When placing their products on the market and making them available to patients and users, manufacturers of medical devices must ensure that they have been designed and manufactured in accordance with the requirements of the European Medical Device Regulation (MDR) 2017/745. The MDR requires manufacturers to have a risk management process that continues throughout the life cycle of the product to ensure ongoing safety. This includes activities during production as well as downstream phases. Risk management is thus a key element in all phases of a medical device’s life.

Identifying and controlling risks through risk management

In addition to the identification and assessment of hazards, risk control measures play an important role in risk management.

The internationally recognized standard for risk management, ISO 14971 “Medical devices – Application of risk management to medical devices”, provides a framework for developing risk management plans and supports manufacturers of medical devices in the implementation of these. This process must be implemented, documented in detail and filed in a risk management file.

Fulfill documentation requirements

The creation of a risk management file in accordance with the ISO 14971 standard enables the tracking of identified risks and includes:
  • Risk analysis, risk control and risk assessment
  • Risk Management Plan (EU RMP): Includes a description of the product, authorities and responsibilities, requirements for reviews, manufacturer’s premises for acceptance of risks, and further on data and information collected before and after commissioning, etc.
  • Risk management report: A final report summarizing the results of the risk management process together with an assessment of the residual risk. It should reflect the effectiveness of the risk management plan and illustrate the acceptability of residual risk in relation to benefits of the device.

Keep knowledge up-to-date

We also offer qualified consulting and training on various risk management approaches such as FMEA (Failure Mode and Effects Analysis).

How Medicoforum supports you

Benefit from our expertise in the area of efficient risk management for medical devices under MDR. We are happy to advise you at every stage of your product’s life cycle.