Medical Device Risk Management File Preparation

Medical Device Manufacturers should prepare a Risk Management File in accordance with the EN ISO 14971 Standard, taking into account the usage location, purpose, and contents of the product they manufacture, and include it in their Technical Files.

Various techniques such as FMA, HACCP, HAZOP, SWIFT, and Risk Probability Matrix can be used for Risk Management. However, it is extremely important for Medical Device Manufacturers to choose the simplest applicable method to carry out an effective Risk Management process. Additionally, the EN ISO 14971 Standard does not impose any specific method for Risk Management.

The goal of Medical Device Risk Management is to identify all risks related to the product’s safety and performance, taking into account the product’s intended use, usage environment, product users, and product contents. The aim is to reduce these risks to the lowest possible levels through the implementation of preventive measures.

With the 2012 revision of the EN ISO 14971 Standard, a new perspective has been introduced to Medical Device Risk Management, likely transitioning from the “Risk reduction: “As Low As Reasonably Practicable” (ALARP)” approach to the “As Low As Practicable” (AFAP) approach. This means that, unlike the previous version of the standard, EN 14971:2007, it is no longer acceptable to reduce risks only with cost-effective solutions for any risk.

The “ALARP” concept primarily implies a financial interpretation. According to the EN ISO 14971 Standard, the justification for not applying risk controls, or for not applying more controls, should be based on valid reasons other than financial considerations.

The EN ISO 14971 Standard indicates three methods to reduce risks and does not accept reducing risks solely through user information methods such as labeling or instructions for use:

  • Design improvements
  • Process improvements
  • User information

When applying Risk Management, it is crucial to consider the three components of risk for effective completion of the process:

  • The risk itself
  • The hazard leading to the risk
  • The potential cause of the risk