Essentials of European Medical Device Regulatory Affairs - October 2019

Conduct Risk Assessment

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

Example Risk Matrix

•

High

3 Medium High

9 8 7 6 5 4 3 2 1

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 The Technical File 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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