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Risk Management in Market Surveillance

Market surveillance authorities often refer to applicable product standards rather than have recourse to independent risk assessment. Standards are especially relevant because in EU legislation, they are widely used for presumption of conformity with the safety requirements. However, risk assessment by market surveillance authorities be called for:

  • when there is a lack of applicable standards,
  • to determine whether or not a product that is found to be non-compliant with the standard is indeed dangerous
  • to estimate the degree of danger
  • to decide on appropriate actions.

This will be based on the estimated probability and the severity of health/safety consequences, which help authorities to grade risks. In the EU, risks are graded under the Rapid Alert System for Non Food Products (RAPEX) as “serious”, requiring rapid action, “moderate”, requiring some form of action, and “low”, for which an EU-wide notification of the risk is not required.

Information on use of risk management in market surveillance

Useful reading

  • Emars: Best practice techniques in market surveillance