Essentials of European Medical Device Regulatory Affairs

European Labelling Requirements (EEA-29 countries of EU and EFTA) • The user should be able to understand how to use the device – translations required e.g. Belgium (Dutch, French, German) • For more specialist products used by a health care professional another language may be acceptable • Discuss with importing country regulatory authority for specific cases

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Labelling and Risk Mitigation

The residual risks should be addressed on the label and in IFU as to ensure that the user is properly informed about the risks using the device and how they can be avoided.

Labelling should be amended if new information should be shared.

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