Essentials of European Medical Device Regulatory Affairs

MDD Amendment Added ER 7.5 Products with a carcinogenic , mutagenic and toxic to reproduction as per Annex 1 of directive 67/548/EEC as amended Phthalates (as listed in annex 1) if they are used in products which are intended to administer and/or remove medicines, must be labelled EN 15986: ‘Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates’ In addition if the devices are used in the treatment of children or nursing or pregnant mothers this warrants specific justification and information on residual risks and must be provided in the IFU.

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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) • Barcodes/UDI – various conventions MDR introduces. Awaiting additional implementing act . • 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’

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