Essentials of European Medical Device Regulatory Affairs

Conduct Risk Assessment

Example Risk Matrix

•

Product not Corporate Requirements • Irreversible injury or fatality never ok • Frequent minor problems require commercial review • Clear acceptability threshold

9 8 7 6 5 4 3 2 1

3 Medium High

High

2

Low Medium High

(L)

1

Low

Low Medium

Likelihood of Harm

1

2

3

3x3 Risk Matrix

Severity of Harm (S)

1 2 3 4 5 6 7 8 9

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Prepare technical documentation Technical Documentation – Annex II 1. Device description and specification, including variants and accessories 2. Information to be supplied by the manufacturer 3. Design and manufacturing information 4. General safety and performance requirements 5. Benefit-risk analysis and risk management 6. Product verification and validation 6.1 Pre-clinical and clinical data 6.2 Additional information required in specific cases

PMS documentation - Annex III – PMS Plan – PMCF Plan – PSUR or PMS report

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