Essentials of European Medical Device Regulatory Affairs

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

Prepare technical documentation

 “ Technical File” demonstrate compliance to the directive  Evidence to show one conforms to the assessment procedure  Evidence of conformity with the Essential Requirements  Prepared and retained by manufacturer – under document control  Auditable  “Design Dossier” if a product falls into Class 3  Content type is the same but extent of detail is usually greater.  Major difference from all other classifications of product submitted to the NB for examination before product can be CE marked  All changes must be submitted prior to implementation