Medical device risk analysis

Risk management is one of the essential process having greater importance for CE marking of a medical device to be sold in the European market. CE certification is mandatory. To obtain CE marking Harmonized Standards must be complied. The Risk management Standard referred in harmonized standard is EN ISO 14971. This standard cover risk management throughout the life of medical devices and for each phase of that life. The risk analysis is an important step when placing products or machines on the market. Risk management is done by identifying the various hazards and their related risks, the control measures and its implementation should be analyzed for a medical device from its initial manufacturing stage to final product output.

How to perform Risk Management for Medical Device?

The first and foremost document to be prepared is the risk management procedure as per EN ISO 13485:2016 which should detail the preparation of documents and performing the risk management activities.

For risk management of a medical device to be CE marked the required documents to be prepared are as follows,

1. Risk Management File – A document which details the description and intended use of the device and various steps involved in risk analysis of various stages of medical device life cycle. The risk management file should consist of a risk management plan, medical device characteristics, and the risk management process and risk management report.

1. Risk Management Plan should detail the methodology of risk analysis, risk evaluation, risk control, risk acceptability criteria and the risk-benefit ratio of a medical device. Risk acceptability criteria are essential for the ultimate effectiveness of the risk management process. For each risk management plan, the manufacturer should choose appropriate risk acceptability criteria. A risk management plan is a part of a risk management file. Annex F- of EN ISO 14971 details the preparation of a risk management plan.
2. Risk Management Process: It is a crucial task in which the hazards for each stage of the medical device life cycle are identified, their foreseeable potential problems associated with the equipment, their related risk is analyzed in both fault and normal conditions. Annex E of EN ISO 14971 provides an idea for identifying the hazards at various stages of the medical device.

The risk management process includes the following steps,

Step 1. Study about the device – Intended use; Device characteristics; Classification according to MDD 93/42/EEC, Annex IX

Step 2. Hazard analysis from design to final product stage

Step 3. Risk Analysis

Step 4. Risk Evaluation (Severity and Probability of each risk)

Step 5. Check for Acceptability Criteria

Step 6. Risk Control Measure

Step 7. Risk Control Implementation

Step 8. Check for Acceptability Criteria

Step 9. Matrix preparation, Based on risk acceptability criteria, if residual risk persist

Step 10. Risk-Benefit ratio

Step 11. Risk Management Report

The entire risk management process should be summarized in the hazard analysis template - hazard traceability matrix.

1. Risk evaluation is performed by calculating the severity and probability for each identified hazards. Annex D, Table D.3 and D.4 of EN ISO 14971:2012 provides the five severity and probability level for a medical device. Information on production and post-production should be monitored to ensure safety. This process ensures that the products can be supplied in the market and are safe to use.
2. Risk Management Report should detail the entire output of the plan performed with concluding the results obtained for the risk management of the medical device. The risk management report confirms the safety, and efficacy potential of the medical device.

"As population susceptibilities are better understood, we will be in a better position than we are in today to make informed decisions about risk management."

Readers can write to me for clarification by email: as@i3cglobal.com

Myself Dr. Ananthi Subash MSc., Ph.D in Biotechnology. Currently specialized in Medical Device Regulatory requirements for US FDA and EU Regulation by involving in Biological Evaluation, Risk Analysis and Clinical Evaluation at I 3 CONSULTING, India.