Module 16 2022

02/09/2022

Examples of Safeguard Measures under Directives

Very few formal invocations

Commission Review of New Approach ● 0 safeguard notifications for AIMD and IVD in 2000 ● No data for the MDD ● Compare with 342 for low voltage equipment, 72 for electromagnetic compatibility and 17 for gas appliances

The Organisation for Professionals in Regulatory Affairs

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Why so Few Instances?

Formal legal measures usually unnecessary

Action usually result of “negotiation” ● Voluntary modification or withdrawal by the manufacturer ● Notified body action to suspend or withdraw certificates

Many examples

The Organisation for Professionals in Regulatory Affairs

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