Medical Device Risk Management File Preparation

Medical device producers should prepare the Risk Management File for products that they have produced in compliance with the EN 14971:2012 Standard and based on the usage area, purpose of use and content of that product. The Risk Management File should be included to the Technical Files.

Different techniques such as FMA, HACCP, HAZOP, SWIFT and Solution Probability Matrix can be used for risk management. It is extremely important for medical device producers to select the simplest applicable method in order to maintain an effective risk management study. Besides, the EN 14971 Standard does not insist any particular method for risk management.

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The purpose of medical device risk management is to determine all risks associated with the ​product safety and performance regarding the product itself, users, patients or the environment that the products are used on (if any) in compliance with the usage purpose and the usage area of the product, product users and the content of the product and to reduce the risks to minimum by precautions.

EN 14971:2012 Standard has brought a new perspective to the medical device risk management and provided the transition from the Risk reduction: “low as long as conceivable” (ALARP) approach to the “low whenever possible” (AFAP), which you have probably frequently heard during inspections. It is not accepted to reduce the risks only with the cost-effective solutions as it states in the previous standard of EN 14971:2007.

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“ALARP” concept involves the concept that mostly refers to the financial issues. The justification of the abeyance of risk controls or the further nonapplicability should be based on another valid ground rather than a financial ground regarding the EN 14971:2012 Standard.

In order to reduce the risks, EN 14971:2012 Standard refers to 3 following methods and it does not accept the user briefings and the risk reductions that have been done only with methods such as the label or the user guide;

  • Recruitment of the design
  • Process recruitment
  • User briefings

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It is extremely important to consider these 3 methods while performing the risk management in order to efficiently perform risk management;

1. The risk itself

2. The hazard that causes the risk

3. The potential cause that forms the risk