Essentials of European Medical Device Regulatory Affairs - June 2020

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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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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Other labelling Requirements

• Electrical products have their own standards in the EN60601 series • Country of origin (depends on destination – not an EU requirement) • Trademarks/copyright references • Environmental/waste disposal information (WEEE directive) • Reimbursement information

BS EN 1041:2008: Information supplied by the manufacturer with medical devices EN 15986: ‘Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates’

And don’t for get the CE mark! – Article 20

But the size is defined in Annex V

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