Essentials of European Medical Device Regulatory Affairs

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’

The Organisationfor Professionals inRegulatory Affairs

CE mark – Annex V

In accordance with the MDR the device or sterile pack (where practicable), the sales pack and the instructions for use must show the CE mark: Not less than 5mm high and must be proportional.

5mm

The Organisationfor Professionals inRegulatory Affairs