Module 16 2022

05/09/2022

Risk Management EU MDR Annex I

Risk control measures

Identify and analyse known and foreseeable hazards

Conform to safety principles Take into account the generally acknowledged state of the art Residual risk associated with each hazard is judged acceptable.

•

•

Eliminate or reduce use error • Reduce as far as possible the risks related to ergonomic features of the device and the environment which the device is intended (Design for patient safety) • Give consideration to the knowledge, experience, education, use environment and the medical and physical conditions of intended users

Estimate and evaluate the risks Intended use and foreseeable Misuse

If necessary amend control measures

•

Establish a Risk Management Plan for each device

Risk control priority • Eliminate or reduce as far as possible through safe design and manufacture • Where appropriate, take adequate protection measures including alarms • Provide information for safety and, where appropriate, training to users

Evaluate the impact of controls through information from production and PMS

Eliminate or control the risks

Residual risk for each hazard and overall residual risk is judged acceptable

The Organisation for Professionals in Regulatory Affairs

15

ENISO14971 requirements

Device Risk management plan 3.4

Risk analysis 4.1 – 4.4

Evaluation of residual risk 7

• Intended use/intended purpose • Hazard identification • Risk estimation

• Overall residual risk acceptabiility

Post-Production Information 9

• Gather and review data and literature to determine if the medical benefits outweigh the overall residual risk.

• System for collecting and reviewing post-production information • Evaluation of information for possible relevance to safety • Review of the risk management file

Risk Evaluation 5 • Risk acceptability decision

Review of Risk Mgt process 8

• Risk management plan appropriately implemented • Overall residual risk acceptable • Appropriate system in place for collecting and reviewing post-production information

Risk Control 6.1 – 6.7 • Option analysis • Implementation • Residual risk evaluation • Risk / benefit analysis • Risks from control measures • Completeness of risk control

The Organisation for Professionals in Regulatory Affairs 16

16